COVID-19
Conditions
Keywords
Immunogenicity, Prime-Boost, Reactogenicity, Safety, SARS-CoV-2, vaccine
Brief summary
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and \>60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson & Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups. The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine.
Detailed description
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and \>60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson & Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups. The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine. The secondary objective of this study is to assess the humoral immunogenicity of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE.
Interventions
Chimpanzee Adenovirus serotype 68 - Spike (ChAdV68-S) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5 mL intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
Chimpanzee Adenovirus 68 - Spike plus additional SARS-CoV-2 T cell epitopes (ChAdV68-S-TCE) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5- or 1.0-mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
Self-Amplifying mRNA - Lipid Nanoparticles - Spike (SAM-LNP-S) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 mL or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
Self-Amplifying mRNA - Lipid Nanoparticles -Spike plus additional SARS-CoV-2 T cell epitopes (SAM-S-TCE) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
The diluent used for this study will be 0.9% Sodium Chloride Injection, USP, and is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives.
Sponsors
Study design
Eligibility
Inclusion criteria
Subjects eligible to participate in this trial must meet all of the following inclusion criteria: 1. Provide written informed consent prior to initiation of any study procedures 2. Able and willing (in the investigator's opinion) to comply with all study requirements 3. Are men or non-pregnant women aged 18 years or older at enrollment 4. Are in good health\* \*As defined by absence of clinically significant medical conditions defined by the CDC as increasing risk for severe corona virus disease-19 (COVID-19) (see
Exclusion criteria
), or other acute or chronic medical conditions determined by medical history, physical examination (PE), screening laboratory test results, and/or clinical assessment of the investigator that are either listed as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | Day 1 to study completion through up to 1 year post last dose | Number of participants that experienced any NOCMCs during the course of the study |
| Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | Day 1 to study completion through up to 1 year post last dose | Number of participants that experienced any PIMMCs during the course of the study |
| Frequency of Any Medically Attended Adverse Events (MAAEs) | Day 1 to study completion through up to 1 year post last dose | Number of participants that experienced any MAAEs during the course of the study |
| Frequency of Any Laboratory AE | Through 7 days post each study vaccination | Number of participants that experienced any laboratory AE |
| Frequency of Any Serious Adverse Events (SAEs) | Day 1 to study completion through up to 1 year post last dose | The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4. | Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. |
| Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4. | Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration. |
| Frequency of Any Unsolicited Adverse Events (AEs) | Day 1 through Day 29 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and 28 days post any vaccination for Groups 1, 3A, 3b and 4. | Number of participants who experienced any unsolicited AEs through 28 days post vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer. |
| Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 |
| Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G |
| Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of RBD titer |
| Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean of RBD titer |
| Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean of RBD titer |
| Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean of S-2P titer |
| Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean of S-2P titer |
| Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean of S-2P titer |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against D614G S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P |
| Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2 |
| Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154 |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154 To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay |
| Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination, Day 15 Post Vaccination | Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive. |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the S1 as measured by ELISpot |
| Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the S2 as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the Spike as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot |
| Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the S1 as measured by ELISpot |
| Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the S2 as measured by ELISpot |
| Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the Spike as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot. |
| Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the S1 as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the S2 as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the Spike as measured by ELISpot. |
| Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1 | Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot. |
| Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 29 Post Vaccination 1, Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Day 29 Post Vaccination 1 | Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay |
| Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vac 1 (85 Days Post Vac 2), Day 265 Post Vac 1 (181 Days Post Vac 2), Day 450 Post Vac 1 (366 Days Post Vac 2) | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer. |
| Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 4 distinct US-based Infectious Diseases Clinical Research Consortium (IDCRC) sites. The first participant was enrolled on March 25, 2021, and the last participant was enrolled on September 29, 2022.
Pre-assignment details
Stage 1 studied dose escalation of homologous and heterologous prime-boost vaccination schedules in healthy naïve adult participants. Stage 2 studied booster vaccination(s) in adult participant who previously received Coronavirus Disease 2019 (COVID-19) Emergency Use Authorization (EUA)/licensed vaccines.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 (Naïve) Group 1 Covid-19 Vaccine and infection Naïve, 18-60years old; received intramuscular (IM) injection of 5 x 10\^10 vp ChAd-S followed by 30 µg SAM-S. | 4 |
| Stage 1 (Naïve) Group 3A Covid-19 Vaccine and infection Naïve, 18-60years old; received intramuscular (IM) injection of 30 µg SAM-S followed by 30 µg SAM-S. | 3 |
| Stage 1 (Naïve) Group 3B Covid-19 Vaccine and infection Naïve, 18-60years old; received intramuscular (IM) injection of 30 µg SAM-S followed by 3 µg SAM-S. | 7 |
| Stage 1 (Naïve) Group 4 Covid-19 Vaccine and infection Naïve, 18-60years old; received intramuscular (IM) injection of 10 µg SAM-S-TCE followed by 3 µg SAM-S-TCE. | 3 |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, 18-60 years old, received a single intramuscular (IM) injection of 3 µg SAM-S-TCE. | 10 |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, 18-60 years old, received a single intramuscular (IM) injection of 6 µg SAM-S-TCE. | 10 |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 3 µg SAM-S-TCE. | 8 |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 6 µg SAM-S-TCE. | 10 |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 10 µg SAM-S-TCE. | 10 |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 5x10\^10 vp ChAd-S-TCE. | 7 |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 1x10\^11 vp ChAd-S-TCE. | 7 |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 Previously (\>/=112 days) dosed with Emergency Use Authorization (EUA)/licensed mRNA vaccine, greater than 60 years old, received a single intramuscular (IM) injection of 5x10\^11 vp ChAd-S-TCE. | 2 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Stage 1 (Naïve) Group 1 | Stage 1 (Naïve) Group 3A | Stage 1 (Naïve) Group 3B | Stage 1 (Naïve) Group 4 | Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 12.6 | 32.5 years STANDARD_DEVIATION 8.9 | 23.3 years STANDARD_DEVIATION 8.4 | 45.4 years STANDARD_DEVIATION 11.7 | 29.3 years STANDARD_DEVIATION 13.6 | 34.0 years STANDARD_DEVIATION 8.7 | 63.4 years STANDARD_DEVIATION 2.8 | 67.8 years STANDARD_DEVIATION 4.7 | 66.0 years STANDARD_DEVIATION 4.5 | 69.1 years STANDARD_DEVIATION 7.1 | 64.7 years STANDARD_DEVIATION 5.3 | 67.5 years STANDARD_DEVIATION 3.5 | 51.0 years STANDARD_DEVIATION 18.2 |
| BMI | 23.46 kg/m^2 STANDARD_DEVIATION 2.94 | 25.23 kg/m^2 STANDARD_DEVIATION 3.48 | 21.03 kg/m^2 STANDARD_DEVIATION 3.18 | 24.51 kg/m^2 STANDARD_DEVIATION 2.11 | 25.57 kg/m^2 STANDARD_DEVIATION 3.44 | 24.79 kg/m^2 STANDARD_DEVIATION 3.05 | 26.03 kg/m^2 STANDARD_DEVIATION 4.46 | 24.77 kg/m^2 STANDARD_DEVIATION 4.31 | 29.26 kg/m^2 STANDARD_DEVIATION 2.69 | 23.33 kg/m^2 STANDARD_DEVIATION 4.35 | 26.61 kg/m^2 STANDARD_DEVIATION 4.74 | 26.55 kg/m^2 STANDARD_DEVIATION 2.47 | 25.00 kg/m^2 STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 4 Participants | 2 Participants | 7 Participants | 3 Participants | 9 Participants | 8 Participants | 10 Participants | 10 Participants | 7 Participants | 7 Participants | 2 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Previous COVID-19 Infection No previous infection | 10 Participants | 4 Participants | 3 Participants | 7 Participants | 3 Participants | 10 Participants | 8 Participants | 8 Participants | 8 Participants | 7 Participants | 6 Participants | 2 Participants | 76 Participants |
| Previous COVID-19 Infection Previous infection | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 4 Participants | 2 Participants | 7 Participants | 3 Participants | 9 Participants | 8 Participants | 10 Participants | 10 Participants | 6 Participants | 7 Participants | 2 Participants | 77 Participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 7 Participants | 5 Participants | 6 Participants | 7 Participants | 5 Participants | 2 Participants | 0 Participants | 42 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 5 Participants | 2 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 10 | 0 / 10 | 0 / 8 | 0 / 10 | 0 / 10 | 0 / 7 | 0 / 7 | 0 / 2 |
| other Total, other adverse events | 4 / 4 | 3 / 3 | 7 / 7 | 3 / 3 | 10 / 10 | 10 / 10 | 8 / 8 | 10 / 10 | 10 / 10 | 7 / 7 | 7 / 7 | 2 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 10 | 0 / 10 | 0 / 8 | 0 / 10 | 0 / 10 | 0 / 7 | 0 / 7 | 0 / 2 |
Outcome results
Frequency of Any Laboratory AE
Number of participants that experienced any laboratory AE
Time frame: Through 7 days post each study vaccination
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any Laboratory AE | 4 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any Laboratory AE | 3 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any Laboratory AE | 7 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any Laboratory AE | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any Laboratory AE | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any Laboratory AE | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any Laboratory AE | 7 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any Laboratory AE | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any Laboratory AE | 10 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any Laboratory AE | 6 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any Laboratory AE | 5 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any Laboratory AE | 0 Participants |
Frequency of Any Medically Attended Adverse Events (MAAEs)
Number of participants that experienced any MAAEs during the course of the study
Time frame: Day 1 to study completion through up to 1 year post last dose
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any Medically Attended Adverse Events (MAAEs) | 4 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 4 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 4 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any Medically Attended Adverse Events (MAAEs) | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any Medically Attended Adverse Events (MAAEs) | 5 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 3 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study
Time frame: Day 1 to study completion through up to 1 year post last dose
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)
Number of participants that experienced any PIMMCs during the course of the study
Time frame: Day 1 to study completion through up to 1 year post last dose
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 1 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 2 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs) | 0 Participants |
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time frame: Day 1 to study completion through up to 1 year post last dose
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
Frequency of Any Unsolicited Adverse Events (AEs)
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
Time frame: Day 1 through Day 29 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and 28 days post any vaccination for Groups 1, 3A, 3b and 4.
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Any Unsolicited Adverse Events (AEs) | 1 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Any Unsolicited Adverse Events (AEs) | 2 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Any Unsolicited Adverse Events (AEs) | 6 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Any Unsolicited Adverse Events (AEs) | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Any Unsolicited Adverse Events (AEs) | 10 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Any Unsolicited Adverse Events (AEs) | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Any Unsolicited Adverse Events (AEs) | 7 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Any Unsolicited Adverse Events (AEs) | 7 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Any Unsolicited Adverse Events (AEs) | 8 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Any Unsolicited Adverse Events (AEs) | 6 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Any Unsolicited Adverse Events (AEs) | 5 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Any Unsolicited Adverse Events (AEs) | 2 Participants |
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
Time frame: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 4 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 3 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 7 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 5 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 9 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 1 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 2 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 1 Participants |
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Time frame: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Population: The Safety Analysis population for the study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 4 Participants |
| Stage 1 (Naïve) Group 3A | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 3 Participants |
| Stage 1 (Naïve) Group 3B | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 7 Participants |
| Stage 1 (Naïve) Group 4 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 3 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 8 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,B | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 3 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 5 Participants |
| Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15 | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 2 Participants |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 1.93 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 28.25 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 11.46 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 13.61 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 2.40 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 57 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 42.65 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 4.27 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 1.00 fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.81 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 86.85 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 18.53 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 7.76 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 8.63 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 7.14 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 13.39 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 74.37 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 7.32 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.95 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 9.20 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 40.58 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.49 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 56.02 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 20.73 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.54 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 11.83 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.74 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.43 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 8.76 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 4.32 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.97 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.88 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 3.35 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 9.95 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 12.26 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 15.55 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.53 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 2.01 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 44.10 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 11.77 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.80 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 3.77 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 4.70 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.12 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1.46 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 3.12 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.29 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 3.91 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.26 fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 169 Post Vac 1 (85 Days Post Vac 2), Day 265 Post Vac 1 (181 Days Post Vac 2), Day 450 Post Vac 1 (366 Days Post Vac 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | NA fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | NA fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.32 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 121.91 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 23.87 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.08 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.45 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 4.89 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 13.56 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 108.81 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.43 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 3.47 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.11 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 17.31 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 3.38 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 12.57 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.64 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 2.95 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 11.53 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.01 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1.66 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.67 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.58 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 2.46 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 4.30 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 4.43 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 25.41 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 11.24 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 21.78 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1.82 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.74 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 84.18 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 11.63 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.85 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 3.66 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 10.54 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.56 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 6.70 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 11.12 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.60 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 9.14 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.78 fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 29 Post Vaccination 1 | 11.90 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | 72.48 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 12.27 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 573.77 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 66.61 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 29 Post Vaccination 1 | 4.06 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 1.57 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | 2.80 fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 29 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 57 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 85 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 1.18 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 1.35 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 1.00 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 258.71 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 42.59 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 130.72 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 29 Post Vaccination 1 | 9.09 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 17.21 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 57 Post Vaccination 1 | 1.86 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 298.33 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 85 Post Vaccination 1 | 1.00 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 9.98 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 23.98 fold rise |
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 3.33 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 30.20 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 14.19 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 4.96 fold rise |
| Stage 1 (Naïve) Group 1 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.02 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 3.62 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.75 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 15.28 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 3.38 fold rise |
| Stage 1 (Naïve) Group 3A | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 3.05 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 8.07 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 10.01 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.64 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 18.02 fold rise |
| Stage 1 (Naïve) Group 3B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 10.84 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 4.06 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 4.83 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.91 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.78 fold rise |
| Stage 1 (Naïve) Group 4 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.60 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.79 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 2.03 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 3.27 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 3.27 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.16 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 11.38 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 13.53 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.90 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 2.15 fold rise |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 21.98 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 9.94 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1.52 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2.86 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 2.54 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.54 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 0.89 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1.88 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.06 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 2.76 fold rise |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 4.55 fold rise |
Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of RBD titer
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.6975 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.5864 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.1134 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.1962 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.1082 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.9271 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.2725 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 6.1054 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.2709 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.8714 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.3735 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.3086 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.4872 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.5427 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.4103 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.5019 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.8233 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 4.8833 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5874 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.2627 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.5201 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.2341 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.3951 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.9260 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.4714 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.2454 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.8235 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.1098 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.6756 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.4238 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 4.7917 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.4978 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.6996 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5399 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 4.3709 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 6.0125 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.7671 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.6336 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 4.7219 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.1222 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.3922 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 4.8502 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.5832 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.1749 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.5803 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 6.2200 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.1950 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.3734 titer |
Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of S-2P titer
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.1647 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.2906 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.7415 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.0318 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5115 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.7937 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 6.0754 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.6841 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.0462 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.5361 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.0642 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5887 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 4.7663 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.1947 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.0168 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 4.8845 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 4.8448 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 4.5982 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.2681 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.2196 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.2691 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.5926 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.1933 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.3569 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5167 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.5084 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.3687 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.1658 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.8548 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.6533 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.0920 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.4640 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.0731 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.5953 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 4.5890 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.3688 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5.8416 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.6251 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.3462 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.6380 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.1322 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 5.3743 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 6.4489 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 5.5236 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 5.0425 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 5.7356 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 5.1096 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 6.1184 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Time frame: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 12.8238 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 1611.5218 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 7.3983 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 28.7301 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 6.9420 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 120.5431 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 84.8521 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 95.1328 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 85.4674 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 57 Post vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 6.6902 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 8.1121 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1779.4509 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 17.7942 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 85.6574 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 153.6259 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 329.7767 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 138.0929 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 238.4406 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 33.4039 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 244.4228 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 2484.3099 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 165.3657 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 447.3343 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 665.0024 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 109.1945 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 77.0553 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 246.0892 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 481.6709 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 11.8710 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 711.0995 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 81.1329 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 141.2683 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 196.8757 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 530.9893 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 959.9418 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 294.2032 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 173.5413 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 875.2497 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 87.9255 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 379.9728 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 253.2367 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 123.3706 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 596.9179 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 97.9557 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 757.4496 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 48.7041 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 2147.7815 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1369.4248 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 711.7177 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 116.3880 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 438.3675 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 546.5955 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 209.5990 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1833.8419 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 2467.0800 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 685.0752 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1459.7959 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 468.5976 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 2008.1706 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 16.3926 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 1345.8006 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 23.6552 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 40.2809 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Time frame: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 54.4021 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 25.9869 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 85.2857 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 74.1983 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1688.7466 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 12.5099 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 54.0724 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 80.7230 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 298.6044 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 76.0077 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 116.9255 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 23.8982 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 129.8719 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 2600.2491 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 82.9652 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 324.0669 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 575.9687 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 280.1679 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 154.9099 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 258.4824 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 793.2778 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 45.8250 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 627.1003 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 94.0770 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 94.8682 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 155.9792 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 277.7532 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1084.8950 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 170.1065 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 94.5667 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 976.0525 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 38.4049 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 252.6360 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 165.0762 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 38.3975 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 236.6733 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 36.6182 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 458.4044 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 21.0485 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1771.7935 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 742.6808 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 360.5940 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 63.8694 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 233.6561 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 673.1993 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 118.0503 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1134.9309 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 717.7161 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 832.4483 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1380.7990 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 124.2137 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 571.0459 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 29 Post Vaccination 1 | 59.4991 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 61.3577 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 362.4094 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 2868.8374 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 333.0359 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 29 Post Vaccination 1 | 20.2886 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 14.0063 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 7.8418 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 29 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 6.7531 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 85 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 57 Post vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 1293.5494 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 5.8980 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 212.9680 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 653.5897 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 29 Post Vaccination 1 | 45.4538 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 57 Post vaccination 1 | 9.2994 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 85 Post Vaccination 1 | 5.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 119.8892 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 86.0638 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 49.9195 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 1491.6390 titer |
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 3531.7642 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 112.8328 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 376.1197 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 566.1029 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1601.5347 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 559.7445 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1468.7289 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 405.4138 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1371.6395 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 6195.9903 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 1237.9613 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 2738.3033 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1853.2904 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 829.7727 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 682.4080 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1114.9642 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1029.1579 titer |
| Stage 1 (Naïve) Group 3B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 102.8466 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 3188.0320 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 482.9330 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 921.5980 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1341.1447 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1963.1115 titer |
| Stage 1 (Naïve) Group 4 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 2333.8724 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1229.7755 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 761.2916 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1936.6356 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 375.5394 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 2175.7877 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1229.6606 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 425.4411 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 1670.9884 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 315.1407 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 1986.5339 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 146.8761 titer |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 3228.9682 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 4276.7890 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 2813.3790 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 430.2308 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 1230.7704 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1093.8728 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 652.4332 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination | 5078.3770 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post Vaccination | 8381.4354 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 366 Post Vaccination | 1645.4066 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination | 3462.6712 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination | 1843.1744 titer |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination | 11176.4335 titer |
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A
Geometric Mean of RBD titer
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 29 Post Vaccination 1 | 4.0128 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 4.3994 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | 5.2779 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 6.5014 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 1.4663 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 5.8002 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 1.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 29 Post Vaccination 1 | 1.3351 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 57 Post Vaccination 1 (29 Days Post Vaccination 2) | 2.3206 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 1.5100 titer |
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4
Geometric Mean of RBD titer
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 29 Post Vaccination 1 | 1.4036 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 1.5587 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 85 Post Vaccination 1 | 1.5076 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 1.3002 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 57 Post Vaccination 1 | 1.0000 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 5.8158 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 1.7037 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 4.7615 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 1.3894 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 5.2214 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 1.8018 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 29 Post Vaccination 1 | 3.4419 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 57 Post Vaccination 1 | 3.3980 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 85 Post Vaccination 1 | 3.5077 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 4.3799 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 4.1463 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 3.9733 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 5.2318 titer |
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A
Geometric Mean of S-2P titer
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 29 Post Vaccination 1 | 4.0618 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 3.5022 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 4.7630 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 5.6119 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 1.8212 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 4.6257 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 1.0000 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 29 Post Vaccination 1 | 1.9543 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 2.6772 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 1.6279 titer |
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4
Geometric Mean of S-2P titer
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 29 Post Vaccination 1 | 2.2027 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 2.0917 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 85 Post Vaccination 1 | 2.0479 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 2.6905 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 57 Post vaccination 1 | 2.3213 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 5.1576 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 2.3037 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 4.5632 titer |
| Stage 1 (Naïve) Group 1 | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 1.2425 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 4.8462 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 1.3426 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 29 Post Vaccination 1 | 3.3798 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 57 Post vaccination 1 | 3.3500 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 85 Post Vaccination 1 | 3.2201 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 4.0985 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 3.9677 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 3.5196 titer |
| Stage 1 (Naïve) Group 3A | Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 4.7234 titer |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0.033 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0.294 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0.216 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0.040 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0.078 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0.090 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.017 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.011 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.028 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.016 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.012 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.017 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.026 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.284 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.192 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.315 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.316 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.182 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.225 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.099 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.111 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.237 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.252 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.166 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.172 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.228 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.149 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.103 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.223 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0.024 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0.013 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.015 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.019 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.018 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.018 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.015 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.015 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.012 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.016 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.019 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.015 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.022 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.010 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.014 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.006 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.006 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.036 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.012 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.014 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.019 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.010 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.008 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.012 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.011 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.001 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.009 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.007 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.005 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0.003 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0.006 percentage of CD4+ T Cells |
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 1 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3A | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 3B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.020 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.002 percentage of CD4+ T Cells |
| Stage 1 (Naïve) Group 4 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.001 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.005 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.009 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.009 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.004 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 0.006 percentage of CD4+ T Cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0.003 percentage of CD4+ T Cells |
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 18.125 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 42.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 24.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 36.071 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 51.111 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 25.938 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 23.125 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 19.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 25.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 32.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 34.688 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 28.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 35.556 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 77.188 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 43.125 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 17.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 64.375 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 55.625 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 19.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 36.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 17.778 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 19.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 21.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 18.611 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 25.278 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 17.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 21.944 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 21.389 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 22.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 20.36 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 16.79 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 17.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 45.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 25.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 28.93 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 54.38 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 28.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 666.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 206.25 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 26.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 54.167 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 37.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 51.250 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 26.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 29 Post Vaccination 1 | 36.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 57 Post vaccination 1 | 40.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 85 Post Vaccination 1 | 18.750 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 21.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 31.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 29 Post Vaccination 1 | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 23.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 72.143 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 68.611 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 39.063 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 57.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 62.222 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 33.056 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 37.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 72.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 49.444 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 48.611 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 97.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 53.750 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 90.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 89.688 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 25.250 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 63.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 17.778 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 37.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 37.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 33.611 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 24.722 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 32.778 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 27.778 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 31.07 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 38.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 18.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 58.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 25.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 38.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 51.88 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 34.38 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 31.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 812.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 268.75 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 37.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 51.250 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 16.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 29 Post Vaccination 1 | 16.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 18.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 22.143 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 17.813 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 19.688 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 21.944 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 16.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 22.813 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 18.889 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 17.778 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 18.438 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 17.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 17.188 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 16.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 30.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 17.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 20.250 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 17.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 16.111 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 16.111 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 18.93 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 15.00 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 29 Post Vaccination 1 | 16.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 29.375 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 21.667 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 29 Post Vaccination 1 | 18.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 28.333 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 29 Post Vaccination 1 | 37.917 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 57 Post vaccination 1 | 40.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 85 Post Vaccination 1 | 18.750 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 21.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 19.375 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 17.083 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 19.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 29 Post Vaccination 1 | 27.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 23.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 42.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 30.278 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 26.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 44.063 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 46.667 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 18.889 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 22.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 34.688 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 31.944 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 28.611 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 31.250 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 23.750 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 20.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 37.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 42.188 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 21.250 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 24.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 19.250 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 22.000 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 28.056 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 22.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 20.556 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 24.167 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 19.722 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 29.29 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 17.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 26.07 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 19.64 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 18.33 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 27.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 17.14 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 26.79 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 18.13 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 20.63 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 22.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 31.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 157.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 70.00 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 61.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 76.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 120.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 257.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 230.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 29.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 37.500 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 29.167 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 34.167 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 25.833 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 31.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 33.125 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 28.333 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 33.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 328.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 28.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 43.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 35.833 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 193.214 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 201.389 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 118.438 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 153.438 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 160.278 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 130.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 157.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 195.938 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 151.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 148.000 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 137.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 112.500 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 109.688 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 170.313 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 163.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 146.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 210.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 56.389 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 117.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 117.750 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 117.222 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 137.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 117.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 105.278 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 95.833 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 140.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 73.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 132.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 118.21 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 82.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 431.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 197.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 437.86 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 415.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 412.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 45.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 40.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 208.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 1157.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 827.50 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 131.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 140.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 250.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 525.833 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 90.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 25.000 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 28.750 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 21.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 16.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 30.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 304.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 83.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 72.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 17.500 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 151.429 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 143.611 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 101.563 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 146.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 143.056 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 143.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 158.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 486.875 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 183.889 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 188.250 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 116.563 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 125.313 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 118.438 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 155.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 150.625 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 115.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 166.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 61.389 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 104.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 101.750 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 131.667 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 124.167 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 124.167 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 116.667 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 79.167 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 139.64 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 95.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 127.14 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 108.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 122.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 93.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 58.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 87.86 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 81.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 83.13 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 25.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 576.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 1360.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 1006.25 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 60.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 74.375 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 123.750 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 241.667 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 166.250 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 18.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 26.667 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 19.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 32.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 21.667 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 31.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 21.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 32.917 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 85.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 74.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 25.000 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 193.929 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 241.667 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 130.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 151.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 159.444 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 155.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 199.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 215.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 173.611 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 225.250 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 128.438 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 94.688 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 103.438 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 139.063 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 128.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 126.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 233.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 101.111 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 132.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 119.000 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 137.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 180.556 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 134.772 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 135.833 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 109.444 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 269.29 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 156.88 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 256.43 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 182.14 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 198.33 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 245.42 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 126.43 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 225.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 217.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 336.88 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 22.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 30.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 65.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 451.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 206.25 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 16.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 49.375 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 36.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 75.833 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 20.625 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 177.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 29 Post Vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 27.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 28.750 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 23.750 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 19.167 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 17.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 23.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 57 Post vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4 | Day 85 Post Vaccination 1 | 21.667 SFU/million cells |
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 83.929 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 72.778 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 56.563 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 81.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 84.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 83.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 71.250 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 157.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 91.944 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 91.500 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 53.125 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 42.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 44.688 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 61.875 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 67.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 80.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 77.250 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 45.556 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 72.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 67.750 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 58.333 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 53.333 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 64.444 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 79.722 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 51.944 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 121.43 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 69.38 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 108.93 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 91.79 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 80.83 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 50.42 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 47.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 48.93 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 32.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 47.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 25.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 31.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 78.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 91.25 SFU/million cells |
Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A
Mean spot forming units per million of the S1 as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 216.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 370.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 775.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 189.375 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 312.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 29.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 55.000 SFU/million cells |
Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4
Mean spot forming units per million of the S1 as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 27.917 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 49.167 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 57 Post vaccination 1 | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 26.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 25.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 33.125 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 44.583 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 324.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 404.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 20.833 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 90.833 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 57 Post vaccination 1 | 43.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 35.833 SFU/million cells |
Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the S1 as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 344.643 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 345.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 218.125 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 300.313 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 303.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 268.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 313.250 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 674.375 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 348.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 334.000 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 249.375 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 230.313 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 224.375 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 322.500 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 306.875 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 254.250 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 371.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 110.833 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 213.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 212.750 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 237.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 247.778 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 243.722 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 209.444 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 160.556 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 276.43 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 165.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 259.64 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 223.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 196.67 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 520.83 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 246.79 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 516.43 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 486.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 488.13 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 45.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 40.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 773.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 2506.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 1833.75 SFU/million cells |
Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A
Mean spot forming units per million of the S2 as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 120.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 156.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 317.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 60.625 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 332.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 36.667 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 25.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 28.750 SFU/million cells |
Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4
Mean spot forming units per million of the S2 as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 41.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 31.250 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 21.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 35.417 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 90.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 74.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 24.167 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 57 Post vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 33.333 SFU/million cells |
Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the S2 as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 311.111 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 271.786 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 232.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 238.611 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 183.438 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 233.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 262.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 308.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 262.222 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 365.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 130.313 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 174.688 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 185.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 190.313 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 138.438 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 136.667 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 178.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 202.750 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 191.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 303.500 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 223.889 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 149.722 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 190.278 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 203.056 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 185.556 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 226.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 365.36 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 390.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 273.93 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 279.17 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 238.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 164.64 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 289.58 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 263.57 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 368.75 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 15.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 297.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 530.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 30.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 88.75 SFU/million cells |
Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A
Mean spot forming units per million of the Spike as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 29 Post Vaccination 1 | 250.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 336.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 527.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 1092.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 637.500 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 1 Pre-Vaccination 1 | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 29 Post Vaccination 1 | 55.833 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 25.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 76.250 SFU/million cells |
Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4
Mean spot forming units per million of the Spike as measured by ELISpot
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 27.917 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 29 Post Vaccination 1 | 77.917 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 57 Post vaccination 1 | 22.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 85 Post Vaccination 1 | 26.875 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 45.625 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 40.000 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 67.500 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 406.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 473.333 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 1 Pre-Vaccination 1 | 20.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 29 Post Vaccination 1 | 20.833 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 105.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 57 Post vaccination 1 | 43.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4 | Day 85 Post Vaccination 1 | 59.167 SFU/million cells |
Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Spike as measured by ELISpot.
Time frame: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 541.944 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 616.429 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 401.563 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 532.813 SFU/million cells |
| Stage 1 (Naïve) Group 1 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 656.111 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 576.000 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 500.750 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 641.250 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 610.556 SFU/million cells |
| Stage 1 (Naïve) Group 3A | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 1038.438 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 510.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 360.938 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 360.625 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 492.813 SFU/million cells |
| Stage 1 (Naïve) Group 3B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 424.063 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 452.500 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 245.833 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 399.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 390.000 SFU/million cells |
| Stage 1 (Naïve) Group 4 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 670.000 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 423.333 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 405.833 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 418.056 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 305.278 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 466.667 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 625.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 667.14 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 391.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 497.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 475.83 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 849.38 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 807.92 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 407.14 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 717.50 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 775.71 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 1 Pre-Vaccination 1 | 855.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 85 Post Vaccination 1 | 70.00 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 15 Post Vaccination 1 | 2131.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 29 Post vaccination 1 | 3036.25 SFU/million cells |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15 | Day 181 Post Vaccination 1 | 45.00 SFU/million cells |
Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 1 arm consists of 3 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 1.837 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.486 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.387 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 3.393 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 1.557 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 1.225 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.761 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 4.618 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.740 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 1.125 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.085 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 11.304 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 1.852 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 5.044 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 4.479 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 10.422 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 8.160 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 8.377 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 5.005 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 18.558 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 13.336 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 31.871 pg/mL |
Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Time frame: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 3 participants as 4 participants did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 6.466 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 1.538 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 1.072 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 9.715 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 3.250 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 3.565 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 1.208 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 13.257 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 2.050 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 3.042 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 0.808 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.271 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 0.161 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 0.156 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 0.070 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 2.167 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.391 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.064 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.341 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 2.534 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 1.361 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 3.895 pg/mL |
Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 2 participants as 5 participants did not have any data reported for this outcome. The Group 4 arm consists of 2 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 22.599 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 11.987 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 26.108 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 37.991 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 15.392 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 42.650 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 329.048 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 80.641 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 30.663 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 367.540 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 12.384 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 1.724 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.569 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.499 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.657 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 1.934 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 1.158 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.144 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.522 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 3.091 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 1.666 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 4.757 pg/mL |
Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 5 and 6 arms consist of 3 participants as 7 participants in each arm did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 6.628 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 1.021 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.778 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 8.160 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 1.533 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 2.561 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 1.124 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 10.722 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.541 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 2.269 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.438 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 6.348 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 1.264 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 2.151 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 2.972 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 21.391 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 5.901 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 5.602 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 3.856 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 27.292 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 9.458 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 36.750 pg/mL |
Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 1 arm consists of 3 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 3.361 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 3.736 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 2.124 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 7.645 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 6.043 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 3.324 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 2.597 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 9.936 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 2.342 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 7.390 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 5.252 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 7.095 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 4.728 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 2.279 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 2.156 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 2.156 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 5.175 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 6.298 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 6.298 pg/mL |
Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Time frame: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 3 participants as 4 participants did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 3.485 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 3.404 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 5.534 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 5.534 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 3.485 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 4.089 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 8.502 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.990 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 8.764 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 3.796 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 1.880 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 1.550 pg/mL |
Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 2 participants as 5 participants did not have any data reported for this outcome. The Group 4 arm consists of 2 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 3.953 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 4.609 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 3.897 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 7.193 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 4.015 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 8.667 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 193.308 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 15.085 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 4.833 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 198.466 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 3.460 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 24.188 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 9.699 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 4.304 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 10.186 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 10.869 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 8.758 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 6.204 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 10.498 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 19.626 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 16.702 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 36.328 pg/mL |
Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 5 and 6 arms consist of 3 participants as 7 participants in each arm did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 2.935 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 1.938 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 2.622 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 3.605 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 2.716 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 2.072 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 2.692 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 4.644 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 2.072 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 6.452 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 3.205 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 3.088 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 3.558 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 1.909 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 1.550 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 3.376 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 1.990 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 2.757 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 3.376 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 2.757 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 5.100 pg/mL |
Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 1 arm consists of 3 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 109.721 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 31.072 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 21.312 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 208.869 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 99.148 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 118.209 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 10.427 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 327.078 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 87.137 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 49.390 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 17.651 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 39.339 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 5.290 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 16.898 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 17.151 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 24.202 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 18.059 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 35.403 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 17.899 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 42.261 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 53.302 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 95.564 pg/mL |
Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Time frame: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 3 participants as 4 participants did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 24.703 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 32.809 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 15.310 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 49.324 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 24.621 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 58.201 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 5.648 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 107.524 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 25.392 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 34.713 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 13.754 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 42.267 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 18.749 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 11.485 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 12.042 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 31.098 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 20.411 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 24.891 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 31.035 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 51.509 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 55.926 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 107.435 pg/mL |
Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 2 participants as 5 participants did not have any data reported for this outcome. The Group 4 arm consists of 2 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 41.112 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 16.322 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 32.492 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 48.035 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 6.923 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 34.309 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 956.979 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 82.343 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 17.987 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 994.717 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 5.246 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 31.671 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 11.715 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 10.155 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 9.801 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 25.725 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 12.611 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 21.148 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 16.493 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 38.335 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 37.641 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 75.976 pg/mL |
Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 5 and 6 arms consist of 3 participants as 7 participants in each arm did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 129.978 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 51.847 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 26.168 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 214.659 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 87.681 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 143.474 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 16.116 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 358.132 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 91.627 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 57.817 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 15.533 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 50.703 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 15.847 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 19.297 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 15.559 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 732.268 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 755.178 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 727.250 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 689.798 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 1487.446 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 1417.047 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 2904.493 pg/mL |
Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 1 arm consists of 3 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.176 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 0.492 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.492 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 0.176 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.128 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 0.656 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.174 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.084 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.097 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.082 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.053 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.131 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.120 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 0.131 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 0.120 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 0.226 pg/mL |
Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Time frame: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 3 participants as 4 participants did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.047 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 0.038 pg/mL |
Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 2 participants as 5 participants did not have any data reported for this outcome. The Group 4 arm consists of 2 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 0.082 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 36.585 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 0.082 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.082 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 36.585 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.493 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.299 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.063 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.186 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.126 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.601 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.075 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.260 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 0.708 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 0.315 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 1.024 pg/mL |
Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 5 and 6 arms consist of 3 participants as 7 participants in each arm did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.059 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 0.097 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.076 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.109 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 0.097 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.098 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 0.047 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 0.052 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 0.038 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 0.056 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 0.052 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 0.056 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 0.071 pg/mL |
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 1 arm consists of 3 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 17.145 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 7.229 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 6.100 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 35.990 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 18.845 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 16.941 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 6.784 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 52.931 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 9.712 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 21.729 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 8.845 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 58.926 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 12.990 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 27.390 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 18.547 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 72.302 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 35.237 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 44.250 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 27.882 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S1 | 107.539 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | S2 | 72.131 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1 | Spike | 179.671 pg/mL |
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Time frame: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 3 participants as 4 participants did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 18.952 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 7.486 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 6.162 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 27.501 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 8.549 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 16.770 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 7.971 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 44.271 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 9.284 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 19.533 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 5.400 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 10.056 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs Spanning Membrane Frame | 3.213 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPa Spanning Nucleocapsid Frame | 4.853 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 15mer OLPs spanning Open Reading Frame 3a | 1.989 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 13.546 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 5.384 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 7.804 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 5.214 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S1 | 18.930 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | S2 | 13.018 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | Spike | 31.948 pg/mL |
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 3B arm consists of 2 participants as 5 participants did not have any data reported for this outcome. The Group 4 arm consists of 2 participants as 1 participant did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 167.163 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 123.765 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 300.416 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 312.503 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 145.340 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 414.445 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 1861.230 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 726.948 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 290.681 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 2290.337 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 128.731 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 10.371 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 3.194 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 3.744 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 3.433 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 10.697 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 5.505 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 6.443 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 6.927 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S1 | 16.202 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | S2 | 13.370 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1 | Spike | 29.572 pg/mL |
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Time frame: Day 29 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. The Group 5 and 6 arms consist of 3 participants as 7 participants in each arm did not have any data reported for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 14.317 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 10.754 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 10.909 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 42.900 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 30.201 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 25.071 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 7.161 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 67.971 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 12.700 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 25.493 pg/mL |
| Stage 1 (Naïve) Group 1 | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 7.423 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a | 48.272 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs Spanning Membrane Frame | 11.752 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPa Spanning Nucleocapsid Frame | 20.224 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | 15mer OLPs spanning Open Reading Frame 3a | 16.296 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools | 209.438 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools | 96.215 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools | 71.193 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S1 | 305.653 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | S2 | 140.002 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Spike | 445.655 pg/mL |
| Stage 1 (Naïve) Group 3A | Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1 | Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools | 68.809 pg/mL |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 S-2P
Time frame: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 75 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 50 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 33 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 33 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 57 Post vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 33 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 0 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 86 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 S-2P
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 75 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P
Time frame: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 60 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 90 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 86 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 86 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P
Time frame: Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 29 Post Vaccination 1 | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 394 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 29 Post Vaccination 1 | 67 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 209 Post Vaccination 1 (181 Days Post Vaccination 2) | 50 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 33 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 57 Post vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 17 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 17 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 0 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 450 Post Vaccination 1 (366 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 29 Post Vaccination 1 | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 113 Post Vaccination 1 (29 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 57 Post vaccination 1 | 67 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 265 Post Vaccination 1 (181 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 169 Post Vaccination 1 (85 Days Post Vaccination 2) | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4 | Day 99 Post Vaccination 1 (15 Days Post Vaccination 2) | 100 percentage of participants |
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against D614G S-2P
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 1 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3A | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 3B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 1 (Naïve) Group 4 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 366 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 181 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 85 Post Vaccination | 100 percentage of participants |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 29 Post Vaccination | 100 percentage of participants |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination | 25 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 75 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 75 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 1 Pre-Vaccination | 50 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 50 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 50 percent of responders |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 89 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 70 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 80 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 80 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 63 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 100 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 38 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 56 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 80 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 70 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 67 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 67 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 57 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 86 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 50 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 50 percent of responders |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154 To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 25 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A | Day 57 Post vaccination 1 (29 Days Post Vaccination 2) | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 1 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 10 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 20 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 10 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 11 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 20 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 14 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 10 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 11 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 20 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 14 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 99 Post vaccination 1 (15 Days Post Vaccination 2) | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 29 Post Vaccination 1 | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4 | Day 85 Post Vaccination 1 | 0 percent of responders |
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154. To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Population: The mITT population includes all enrolled participants who received at least one dose vaccine and contributed both pre- and at least one post vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 1 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3A | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 13 percent of responders |
| Stage 1 (Naïve) Group 3B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 1 (Naïve) Group 4 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9 | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 1 Pre-Vaccination | 0 percent of responders |
| Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,B | Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 | Day 15 Post-Vaccination | 0 percent of responders |