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Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults

A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of Heterologous and Homologous Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04776317
Enrollment
81
Registered
2021-03-01
Start date
2021-03-25
Completion date
2023-09-15
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

BIOLOGICALChAdV68-S

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.

BIOLOGICALChAdV68-S-TCE

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.

BIOLOGICALSAM-LNP-S

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.

BIOLOGICALSAM-LNP-S-TCE

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

Gritstone bio, Inc.
CollaboratorINDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)Day 1 to study completion through up to 1 year post last doseNumber 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 doseNumber 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 doseNumber of participants that experienced any MAAEs during the course of the study
Frequency of Any Laboratory AEThrough 7 days post each study vaccinationNumber 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 doseThe 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

MeasureTime frameDescription
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric 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 3ADay 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 3ADay 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 3ADay 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 4Day 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 1Geometric 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 15Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric 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 15Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric 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 4Day 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 1Geometric 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 4Day 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 15Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 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 4Day 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 1Geometric 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 15Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric Mean of RBD titer
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 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 4Day 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 1Geometric 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 15Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric Mean of S-2P titer
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 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 3ADay 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 3ADay 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 4Day 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 1Percent 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 4Day 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 1Percent 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 4Day 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 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationPercent 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 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationPercent 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 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationPercent 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 3ADay 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 3ADay 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationMean 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 3ADay 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 3ADay 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 4Day 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 1Day 29 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 15Day 1 Pre-Vaccination, Day 15 Post VaccinationPercent 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 3ADay 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 4Day 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 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 15Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 3ADay 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 1Day 29 Post Vaccination 1Mean 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 3ADay 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 3ADay 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 4Day 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 1Geometric 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 4Day 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 1Geometric 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 4Day 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 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric 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 15Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post VaccinationGeometric 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

ArmCount
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
Total81

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014
Overall StudyPhysician Decision010000000000000
Overall StudyProtocol Violation001000000000000
Overall StudyWithdrawal by Subject000010000000000

Baseline characteristics

CharacteristicStage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Stage 1 (Naïve) Group 1Stage 1 (Naïve) Group 3AStage 1 (Naïve) Group 3BStage 1 (Naïve) Group 4Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BStage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BStage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Total
Age, Continuous32.9 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
BMI23.46 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 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants4 Participants2 Participants7 Participants3 Participants9 Participants8 Participants10 Participants10 Participants7 Participants7 Participants2 Participants79 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Previous COVID-19 Infection
No previous infection
10 Participants4 Participants3 Participants7 Participants3 Participants10 Participants8 Participants8 Participants8 Participants7 Participants6 Participants2 Participants76 Participants
Previous COVID-19 Infection
Previous infection
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants2 Participants0 Participants1 Participants0 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants4 Participants2 Participants7 Participants3 Participants9 Participants8 Participants10 Participants10 Participants6 Participants7 Participants2 Participants77 Participants
Sex: Female, Male
Female
6 Participants0 Participants0 Participants4 Participants0 Participants7 Participants5 Participants6 Participants7 Participants5 Participants2 Participants0 Participants42 Participants
Sex: Female, Male
Male
4 Participants4 Participants3 Participants3 Participants3 Participants3 Participants3 Participants4 Participants3 Participants2 Participants5 Participants2 Participants39 Participants

Adverse events

Event typeEG000
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 / 40 / 30 / 70 / 30 / 100 / 100 / 80 / 100 / 100 / 70 / 70 / 2
other
Total, other adverse events
4 / 43 / 37 / 73 / 310 / 1010 / 108 / 810 / 1010 / 107 / 77 / 72 / 2
serious
Total, serious adverse events
0 / 40 / 30 / 70 / 30 / 100 / 100 / 80 / 100 / 100 / 70 / 70 / 2

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any Laboratory AE4 Participants
Stage 1 (Naïve) Group 3AFrequency of Any Laboratory AE3 Participants
Stage 1 (Naïve) Group 3BFrequency of Any Laboratory AE7 Participants
Stage 1 (Naïve) Group 4Frequency of Any Laboratory AE3 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any Laboratory AE8 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any Laboratory AE8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Any Laboratory AE7 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Any Laboratory AE8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Any Laboratory AE10 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any Laboratory AE6 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any Laboratory AE5 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any Laboratory AE0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 1 (Naïve) Group 3AFrequency of Any Medically Attended Adverse Events (MAAEs)1 Participants
Stage 1 (Naïve) Group 3BFrequency of Any Medically Attended Adverse Events (MAAEs)4 Participants
Stage 1 (Naïve) Group 4Frequency of Any Medically Attended Adverse Events (MAAEs)1 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any Medically Attended Adverse Events (MAAEs)4 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any Medically Attended Adverse Events (MAAEs)4 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Any Medically Attended Adverse Events (MAAEs)3 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Any Medically Attended Adverse Events (MAAEs)3 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Any Medically Attended Adverse Events (MAAEs)5 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any Medically Attended Adverse Events (MAAEs)3 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any Medically Attended Adverse Events (MAAEs)1 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 1 (Naïve) Group 3AFrequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 1 (Naïve) Group 3BFrequency of Any New-onset Chronic Medical Conditions (NOCMCs)2 Participants
Stage 1 (Naïve) Group 4Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)2 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency 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,BFrequency 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,BFrequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 1 (Naïve) Group 3AFrequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 1 (Naïve) Group 3BFrequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)1 Participants
Stage 1 (Naïve) Group 4Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)2 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency 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,BFrequency 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,BFrequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 1 (Naïve) Group 3AFrequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 1 (Naïve) Group 3BFrequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 1 (Naïve) Group 4Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any Serious Adverse Events (SAEs)0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Any Unsolicited Adverse Events (AEs)1 Participants
Stage 1 (Naïve) Group 3AFrequency of Any Unsolicited Adverse Events (AEs)2 Participants
Stage 1 (Naïve) Group 3BFrequency of Any Unsolicited Adverse Events (AEs)6 Participants
Stage 1 (Naïve) Group 4Frequency of Any Unsolicited Adverse Events (AEs)3 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Any Unsolicited Adverse Events (AEs)10 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Any Unsolicited Adverse Events (AEs)8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Any Unsolicited Adverse Events (AEs)7 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Any Unsolicited Adverse Events (AEs)7 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Any Unsolicited Adverse Events (AEs)8 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Any Unsolicited Adverse Events (AEs)6 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Any Unsolicited Adverse Events (AEs)5 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Any Unsolicited Adverse Events (AEs)2 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Local Solicited Reactogenicity Adverse Events (AEs)4 Participants
Stage 1 (Naïve) Group 3AFrequency of Local Solicited Reactogenicity Adverse Events (AEs)3 Participants
Stage 1 (Naïve) Group 3BFrequency of Local Solicited Reactogenicity Adverse Events (AEs)7 Participants
Stage 1 (Naïve) Group 4Frequency of Local Solicited Reactogenicity Adverse Events (AEs)3 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Local Solicited Reactogenicity Adverse Events (AEs)10 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Local Solicited Reactogenicity Adverse Events (AEs)8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Local Solicited Reactogenicity Adverse Events (AEs)5 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Local Solicited Reactogenicity Adverse Events (AEs)8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Local Solicited Reactogenicity Adverse Events (AEs)9 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Local Solicited Reactogenicity Adverse Events (AEs)1 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Local Solicited Reactogenicity Adverse Events (AEs)2 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Local Solicited Reactogenicity Adverse Events (AEs)1 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 (Naïve) Group 1Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)4 Participants
Stage 1 (Naïve) Group 3AFrequency of Systemic Solicited Reactogenicity Adverse Events (AEs)3 Participants
Stage 1 (Naïve) Group 3BFrequency of Systemic Solicited Reactogenicity Adverse Events (AEs)7 Participants
Stage 1 (Naïve) Group 4Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)3 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)10 Participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)10 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)8 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BFrequency of Systemic Solicited Reactogenicity Adverse Events (AEs)10 Participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 11A,BFrequency of Systemic Solicited Reactogenicity Adverse Events (AEs)10 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 13Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)3 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 14Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)5 Participants
Stage 2 (ChAd-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 15Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)2 Participants
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 29 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 85 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)1.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)1.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)1.93 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)28.25 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)11.46 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)13.61 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)2.40 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 29 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 57 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)42.65 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 85 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)4.27 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)1.00 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.81 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination86.85 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination18.53 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination7.76 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination8.63 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination7.14 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination13.39 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination74.37 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination7.32 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.95 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination9.20 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination40.58 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.49 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination56.02 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination20.73 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.54 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination11.83 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.74 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.43 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination8.76 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination4.32 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.97 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.88 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination3.35 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination9.95 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination12.26 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination15.55 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.53 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination2.01 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination44.10 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination11.77 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.80 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination3.77 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination4.70 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.12 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1.46 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination3.12 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.29 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination3.91 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.26 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)NA fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)NA fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.32 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination121.91 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination23.87 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.08 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.45 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination4.89 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination13.56 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination108.81 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.43 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination3.47 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.11 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination17.31 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination3.38 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination12.57 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.64 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination2.95 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination11.53 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.01 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1.66 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.67 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.58 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination2.46 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination4.30 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination4.43 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination25.41 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination11.24 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination21.78 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1.82 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.74 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination84.18 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination11.63 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.85 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination3.66 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination10.54 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.56 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination6.70 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination11.12 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.60 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination9.14 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.78 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 29 Post Vaccination 111.90 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)72.48 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)12.27 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)573.77 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)66.61 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 29 Post Vaccination 14.06 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)1.57 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)2.80 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 29 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 57 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 85 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)1.18 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)1.35 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)1.00 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)258.71 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)42.59 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)130.72 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 29 Post Vaccination 19.09 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)17.21 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 57 Post Vaccination 11.86 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)298.33 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 85 Post Vaccination 11.00 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)9.98 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)23.98 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination3.33 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination30.20 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination14.19 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination4.96 fold rise
Stage 1 (Naïve) Group 1Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.02 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination3.62 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.75 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination15.28 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination3.38 fold rise
Stage 1 (Naïve) Group 3AGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination3.05 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination8.07 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination10.01 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.64 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination18.02 fold rise
Stage 1 (Naïve) Group 3BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination10.84 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination4.06 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination4.83 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.91 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.78 fold rise
Stage 1 (Naïve) Group 4Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.60 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.79 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination2.03 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination3.27 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination3.27 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.16 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination11.38 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination13.53 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.90 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination2.15 fold rise
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination21.98 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination9.94 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1.52 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2.86 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination2.54 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.54 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination0.89 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1.88 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.06 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination2.76 fold rise
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination4.55 fold rise
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.6975 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.5864 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.1134 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.1962 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.1082 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.9271 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.2725 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination6.1054 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.2709 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.8714 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.3735 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.3086 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.4872 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.5427 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.4103 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.5019 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.8233 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination4.8833 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5874 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.2627 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.5201 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.2341 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.3951 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.9260 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.4714 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.2454 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.8235 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.1098 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.6756 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.4238 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination4.7917 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.4978 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.6996 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5399 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination4.3709 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination6.0125 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.7671 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.6336 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination4.7219 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.1222 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.3922 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination4.8502 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.5832 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.1749 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.5803 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination6.2200 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.1950 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.3734 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.1647 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.2906 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.7415 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.0318 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5115 titer
Stage 1 (Naïve) Group 1Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.7937 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination6.0754 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.6841 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.0462 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.5361 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.0642 titer
Stage 1 (Naïve) Group 3AGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5887 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination4.7663 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.1947 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.0168 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination4.8845 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination4.8448 titer
Stage 1 (Naïve) Group 3BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination4.5982 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.2681 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.2196 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.2691 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.5926 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.1933 titer
Stage 1 (Naïve) Group 4Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.3569 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5167 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.5084 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.3687 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.1658 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.8548 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.6533 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.0920 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.4640 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.0731 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.5953 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination4.5890 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.3688 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5.8416 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.6251 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.3462 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.6380 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.1322 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination5.3743 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination6.4489 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination5.5236 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination5.0425 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination5.7356 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination5.1096 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination6.1184 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)12.8238 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)1611.5218 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)7.3983 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)28.7301 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 29 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)6.9420 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)120.5431 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 85 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)84.8521 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)95.1328 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)85.4674 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 29 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 57 Post vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 85 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)6.6902 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)8.1121 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1779.4509 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination17.7942 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination85.6574 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination153.6259 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination329.7767 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination138.0929 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination238.4406 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination33.4039 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination244.4228 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination2484.3099 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination165.3657 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination447.3343 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination665.0024 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination109.1945 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination77.0553 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination246.0892 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination481.6709 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination11.8710 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination711.0995 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination81.1329 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination141.2683 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination196.8757 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination530.9893 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination959.9418 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination294.2032 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination173.5413 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination875.2497 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination87.9255 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination379.9728 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination253.2367 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination123.3706 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination596.9179 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination97.9557 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination757.4496 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination48.7041 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination2147.7815 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1369.4248 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination711.7177 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination116.3880 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination438.3675 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination546.5955 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination209.5990 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1833.8419 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination2467.0800 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination685.0752 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1459.7959 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination468.5976 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination2008.1706 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)16.3926 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)1345.8006 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)23.6552 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)40.2809 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)54.4021 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)25.9869 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)85.2857 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)74.1983 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1688.7466 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination12.5099 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination54.0724 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination80.7230 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination298.6044 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination76.0077 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination116.9255 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination23.8982 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination129.8719 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination2600.2491 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination82.9652 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination324.0669 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination575.9687 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination280.1679 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination154.9099 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination258.4824 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination793.2778 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination45.8250 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination627.1003 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination94.0770 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination94.8682 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination155.9792 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination277.7532 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1084.8950 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination170.1065 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination94.5667 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination976.0525 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination38.4049 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination252.6360 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination165.0762 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination38.3975 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination236.6733 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination36.6182 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination458.4044 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination21.0485 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1771.7935 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination742.6808 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination360.5940 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination63.8694 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination233.6561 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination673.1993 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination118.0503 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1134.9309 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination717.7161 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination832.4483 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1380.7990 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination124.2137 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination571.0459 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 29 Post Vaccination 159.4991 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)61.3577 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)362.4094 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)2868.8374 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)333.0359 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 29 Post Vaccination 120.2886 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)14.0063 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)7.8418 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 29 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)6.7531 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 85 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)5.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 57 Post vaccination 15.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)1293.5494 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)5.8980 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)212.9680 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)653.5897 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 1 Pre-Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 29 Post Vaccination 145.4538 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 57 Post vaccination 19.2994 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 85 Post Vaccination 15.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)119.8892 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)86.0638 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)49.9195 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)1491.6390 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination3531.7642 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination112.8328 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination376.1197 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination566.1029 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1601.5347 titer
Stage 1 (Naïve) Group 1Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination559.7445 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1468.7289 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination405.4138 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1371.6395 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination6195.9903 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination1237.9613 titer
Stage 1 (Naïve) Group 3AGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination2738.3033 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1853.2904 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination829.7727 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination682.4080 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1114.9642 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1029.1579 titer
Stage 1 (Naïve) Group 3BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination102.8466 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination3188.0320 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination482.9330 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination921.5980 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1341.1447 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1963.1115 titer
Stage 1 (Naïve) Group 4Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination2333.8724 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1229.7755 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination761.2916 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1936.6356 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination375.5394 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination2175.7877 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1229.6606 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination425.4411 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination1670.9884 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination315.1407 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination1986.5339 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination146.8761 titer
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination3228.9682 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination4276.7890 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination2813.3790 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination430.2308 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination1230.7704 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1093.8728 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination652.4332 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination5078.3770 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post Vaccination8381.4354 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 366 Post Vaccination1645.4066 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination3462.6712 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination1843.1744 titer
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BGeometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination11176.4335 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 29 Post Vaccination 14.0128 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)4.3994 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)5.2779 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)6.5014 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 1 Pre-Vaccination 11.4663 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)5.8002 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 1 Pre-Vaccination 11.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 29 Post Vaccination 11.3351 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 57 Post Vaccination 1 (29 Days Post Vaccination 2)2.3206 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)1.5100 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 29 Post Vaccination 11.4036 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)1.5587 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 85 Post Vaccination 11.5076 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)1.3002 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 57 Post Vaccination 11.0000 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)5.8158 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)1.7037 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)4.7615 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 1 Pre-Vaccination 11.3894 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)5.2214 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 1 Pre-Vaccination 11.8018 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 29 Post Vaccination 13.4419 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 57 Post Vaccination 13.3980 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 85 Post Vaccination 13.5077 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)4.3799 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)4.1463 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)3.9733 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)5.2318 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 29 Post Vaccination 14.0618 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)3.5022 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)4.7630 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)5.6119 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 1 Pre-Vaccination 11.8212 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)4.6257 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 1 Pre-Vaccination 11.0000 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 29 Post Vaccination 11.9543 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)2.6772 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)1.6279 titer
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 29 Post Vaccination 12.2027 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)2.0917 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 85 Post Vaccination 12.0479 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)2.6905 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 57 Post vaccination 12.3213 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)5.1576 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)2.3037 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)4.5632 titer
Stage 1 (Naïve) Group 1Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 1 Pre-Vaccination 11.2425 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)4.8462 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 1 Pre-Vaccination 11.3426 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 29 Post Vaccination 13.3798 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 57 Post vaccination 13.3500 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 85 Post Vaccination 13.2201 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)4.0985 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)3.9677 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)3.5196 titer
Stage 1 (Naïve) Group 3AGeometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)4.7234 titer
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 1 Pre-Vaccination0.033 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 29 Post Vaccination 10.294 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0.216 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 1 Pre-Vaccination0.040 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 29 Post Vaccination 10.078 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0.090 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.007 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.017 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.011 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.028 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.016 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.012 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.017 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.026 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.284 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.192 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.315 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.316 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.182 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.225 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.099 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.111 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.237 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.252 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.166 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.172 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.228 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.149 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.103 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.223 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 3ADay 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 3ADay 29 Post Vaccination 10.024 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0.013 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 3ADay 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 3ADay 29 Post Vaccination 10.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 4Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 4Day 85 Post Vaccination 10.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 4Day 1 Pre-Vaccination0.015 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 4Day 29 Post Vaccination 10.019 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.018 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.008 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.018 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.006 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.015 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.015 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.007 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.012 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.016 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.019 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.011 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.015 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.022 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.010 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.014 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.007 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.007 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.011 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.006 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.006 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.007 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.036 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.006 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.012 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.008 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.011 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.011 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.014 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.011 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.011 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.008 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.019 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.007 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.008 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.008 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.010 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.008 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.006 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.012 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.011 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10.001 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.006 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.009 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.007 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.006 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.005 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0.003 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0.004 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10.006 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination0.001 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination0.020 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination0.002 percentage of CD4+ T Cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination0.001 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination0.005 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination0.009 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination0.009 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination0.004 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination0.006 percentage of CD4+ T Cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination0.003 percentage of CD4+ T Cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)18.125 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)42.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)24.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)15.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 136.071 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 151.111 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 125.938 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 123.125 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 119.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 125.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 132.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 134.688 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 128.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 135.556 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 177.188 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 143.125 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 117.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 164.375 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 155.625 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 119.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 136.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 117.778 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 119.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 121.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 118.611 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 125.278 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 117.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 121.944 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 121.389 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 122.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 120.36 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 116.79 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 117.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 145.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 125.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 128.93 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 154.38 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 128.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1666.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1206.25 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)26.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)54.167 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)37.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)51.250 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 1 Pre-Vaccination 126.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 29 Post Vaccination 136.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 57 Post vaccination 140.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 85 Post Vaccination 118.750 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)21.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)31.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 29 Post Vaccination 124.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)24.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)23.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination 172.143 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 181 Post Vaccination 168.611 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 85 Post Vaccination 139.063 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 29 Post vaccination 157.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination 162.222 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination 133.056 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 85 Post Vaccination 137.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 181 Post Vaccination 172.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 29 Post vaccination 149.444 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination 148.611 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination 197.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 181 Post Vaccination 153.750 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination 122.500 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 85 Post Vaccination 190.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 29 Post vaccination 189.688 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 29 Post vaccination 125.250 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 181 Post Vaccination 163.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination 117.778 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination 122.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 85 Post Vaccination 137.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 29 Post vaccination 137.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination 133.611 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination 124.722 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 85 Post Vaccination 132.778 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 181 Post Vaccination 127.778 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 29 Post vaccination 131.07 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination 138.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination 118.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 29 Post vaccination 158.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination 125.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination 138.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 181 Post Vaccination 151.88 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 85 Post Vaccination 134.38 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination 131.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 29 Post vaccination 1812.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination 1268.75 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)37.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)51.250 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 1 Pre-Vaccination 116.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 29 Post Vaccination 116.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)18.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 122.143 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 117.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 117.813 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 119.688 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 121.944 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 116.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 122.813 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 118.889 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 117.778 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 118.438 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 117.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 117.188 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 116.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 130.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 117.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 120.250 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 117.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 116.111 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 115.000 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.000 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 116.111 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 118.93 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 115.00 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 29 Post Vaccination 116.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)29.375 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)21.667 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 29 Post Vaccination 118.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 1 Pre-Vaccination 128.333 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 29 Post Vaccination 137.917 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 57 Post vaccination 140.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 85 Post Vaccination 118.750 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)21.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)19.375 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)17.083 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 1 Pre-Vaccination 119.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 29 Post Vaccination 127.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)24.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)23.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 142.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 130.278 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 126.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 144.063 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 146.667 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 118.889 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 122.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 134.688 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 131.944 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 128.611 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 131.250 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 123.750 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 120.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 137.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 142.188 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 121.250 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 124.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 119.250 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 122.000 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 128.056 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 122.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 120.556 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 124.167 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 119.722 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 129.29 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 117.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 126.07 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 119.64 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 118.33 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 127.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 117.14 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 126.79 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 118.13 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 120.63 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 122.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 131.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1157.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 170.00 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 161.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)76.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)120.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)257.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 117.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)230.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 129.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)37.500 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 129.167 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 134.167 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 125.833 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 131.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)22.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)33.125 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)28.333 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)33.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)328.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 124.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)28.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 143.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 135.833 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination 1193.214 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 181 Post Vaccination 1201.389 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 85 Post Vaccination 1118.438 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 29 Post vaccination 1153.438 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination 1160.278 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination 1130.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 85 Post Vaccination 1157.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 181 Post Vaccination 1195.938 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 29 Post vaccination 1151.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination 1148.000 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination 1137.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 181 Post Vaccination 1112.500 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination 1109.688 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 85 Post Vaccination 1170.313 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 29 Post vaccination 1163.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 29 Post vaccination 1146.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 181 Post Vaccination 1210.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination 156.389 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination 1117.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 85 Post Vaccination 1117.750 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 29 Post vaccination 1117.222 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination 1137.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination 1117.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 85 Post Vaccination 1105.278 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 181 Post Vaccination 195.833 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 29 Post vaccination 1140.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 85 Post Vaccination 173.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination 1132.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination 1118.21 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 181 Post Vaccination 182.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 29 Post vaccination 1431.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination 1197.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination 1437.86 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 181 Post Vaccination 1415.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 85 Post Vaccination 1412.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 181 Post Vaccination 145.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 85 Post Vaccination 140.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination 1208.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 29 Post vaccination 11157.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination 1827.50 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 1131.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)140.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)250.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)525.833 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)90.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)25.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 128.750 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)21.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)16.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)30.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)304.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)83.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)72.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 117.500 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination 1151.429 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 181 Post Vaccination 1143.611 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 85 Post Vaccination 1101.563 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 29 Post vaccination 1146.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination 1143.056 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination 1143.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 85 Post Vaccination 1158.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 181 Post Vaccination 1486.875 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 29 Post vaccination 1183.889 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination 1188.250 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination 1116.563 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 181 Post Vaccination 1125.313 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination 1118.438 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 85 Post Vaccination 1155.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 29 Post vaccination 1150.625 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 29 Post vaccination 1115.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 181 Post Vaccination 1166.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination 161.389 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination 1104.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 85 Post Vaccination 1101.750 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 29 Post vaccination 1131.667 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination 1124.167 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination 1124.167 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 85 Post Vaccination 1116.667 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 181 Post Vaccination 179.167 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 29 Post vaccination 1139.64 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 85 Post Vaccination 195.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination 1127.14 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination 1108.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 181 Post Vaccination 1122.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 29 Post vaccination 193.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination 158.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination 187.86 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 181 Post Vaccination 181.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 85 Post Vaccination 183.13 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 85 Post Vaccination 125.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination 1576.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 29 Post vaccination 11360.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination 11006.25 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 160.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)74.375 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)123.750 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)241.667 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)166.250 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 118.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 126.667 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)19.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 132.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 121.667 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)31.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)21.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)32.917 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)85.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)74.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)22.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 125.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination 1193.929 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 181 Post Vaccination 1241.667 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 85 Post Vaccination 1130.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 29 Post vaccination 1151.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination 1159.444 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination 1155.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 85 Post Vaccination 1199.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 181 Post Vaccination 1215.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 29 Post vaccination 1173.611 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination 1225.250 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination 1128.438 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 181 Post Vaccination 194.688 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination 1103.438 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 85 Post Vaccination 1139.063 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 29 Post vaccination 1128.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 29 Post vaccination 1126.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 181 Post Vaccination 1233.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination 1101.111 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination 1132.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 85 Post Vaccination 1119.000 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 29 Post vaccination 1137.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination 1180.556 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination 1134.772 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 85 Post Vaccination 1135.833 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 181 Post Vaccination 1109.444 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 29 Post vaccination 1269.29 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 85 Post Vaccination 1156.88 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination 1256.43 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination 1182.14 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 181 Post Vaccination 1198.33 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 29 Post vaccination 1245.42 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination 1126.43 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination 1225.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 181 Post Vaccination 1217.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 85 Post Vaccination 1336.88 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 181 Post Vaccination 122.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 85 Post Vaccination 130.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination 165.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 29 Post vaccination 1451.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination 1206.25 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 116.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)49.375 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)36.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)75.833 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 120.625 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)177.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 1 Pre-Vaccination 117.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 29 Post Vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)27.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)28.750 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 123.750 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 119.167 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 117.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)17.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)23.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)24.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 57 Post vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4Day 85 Post Vaccination 121.667 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 15Day 1 Pre-Vaccination 183.929 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 181 Post Vaccination 172.778 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 85 Post Vaccination 156.563 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 29 Post vaccination 181.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean 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 15Day 15 Post Vaccination 184.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 15 Post Vaccination 183.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 85 Post Vaccination 171.250 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 181 Post Vaccination 1157.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 29 Post vaccination 191.944 SFU/million cells
Stage 1 (Naïve) Group 3AMean 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 15Day 1 Pre-Vaccination 191.500 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 15 Post Vaccination 153.125 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 181 Post Vaccination 142.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 1 Pre-Vaccination 144.688 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 85 Post Vaccination 161.875 SFU/million cells
Stage 1 (Naïve) Group 3BMean 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 15Day 29 Post vaccination 167.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 29 Post vaccination 180.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 181 Post Vaccination 177.250 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 1 Pre-Vaccination 145.556 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 15 Post Vaccination 172.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean 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 15Day 85 Post Vaccination 167.750 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 29 Post vaccination 158.333 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 1 Pre-Vaccination 153.333 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 15 Post Vaccination 164.444 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 85 Post Vaccination 179.722 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean 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 15Day 181 Post Vaccination 151.944 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 29 Post vaccination 1121.43 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 85 Post Vaccination 169.38 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 15 Post Vaccination 1108.93 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 1 Pre-Vaccination 191.79 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean 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 15Day 181 Post Vaccination 180.83 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 29 Post vaccination 150.42 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 1 Pre-Vaccination 147.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 15 Post Vaccination 148.93 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 181 Post Vaccination 132.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean 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 15Day 85 Post Vaccination 147.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 85 Post Vaccination 125.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 1 Pre-Vaccination 131.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 29 Post vaccination 178.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean 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 15Day 15 Post Vaccination 191.25 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)216.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)370.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)775.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 29 Post Vaccination 1189.375 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)312.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 29 Post Vaccination 129.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)55.000 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 1 Pre-Vaccination 127.917 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 29 Post Vaccination 149.167 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 57 Post vaccination 122.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 85 Post Vaccination 126.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)25.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)33.125 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)44.583 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)324.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)404.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 29 Post Vaccination 120.833 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 1 Pre-Vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)90.833 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 57 Post vaccination 143.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 3B and 4Day 85 Post Vaccination 135.833 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1344.643 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1345.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1218.125 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1300.313 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1303.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1268.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1313.250 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1674.375 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1348.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1334.000 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1249.375 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1230.313 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1224.375 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1322.500 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1306.875 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1254.250 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1371.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1110.833 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1213.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1212.750 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1237.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1247.778 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1243.722 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1209.444 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1160.556 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1276.43 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1165.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1259.64 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1223.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1196.67 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1520.83 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1246.79 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1516.43 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1486.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1488.13 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 145.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 140.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1773.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 12506.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 11833.75 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)120.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)156.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)317.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 29 Post Vaccination 160.625 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)332.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 29 Post Vaccination 136.667 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)25.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)28.750 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 29 Post Vaccination 141.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 85 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)31.250 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)21.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)35.417 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)90.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)74.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 29 Post Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)24.167 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 57 Post vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 3B and 4Day 85 Post Vaccination 133.333 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1311.111 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1271.786 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1232.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1238.611 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1183.438 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1233.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1262.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1308.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1262.222 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1365.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1130.313 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1174.688 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1185.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1190.313 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1138.438 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1136.667 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1178.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1202.750 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1191.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1303.500 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1223.889 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1149.722 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1190.278 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1203.056 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1185.556 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1226.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1365.36 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1390.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1273.93 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1279.17 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1238.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1164.64 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1289.58 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1263.57 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1368.75 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 115.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1297.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1530.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 130.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 188.75 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 29 Post Vaccination 1250.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)336.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)527.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)1092.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)637.500 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 1 Pre-Vaccination 115.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 29 Post Vaccination 155.833 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)25.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)76.250 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 1 Pre-Vaccination 127.917 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 29 Post Vaccination 177.917 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 57 Post vaccination 122.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 85 Post Vaccination 126.875 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)45.625 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)40.000 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)67.500 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)406.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)473.333 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 1 Pre-Vaccination 120.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 29 Post Vaccination 120.833 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)105.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 57 Post vaccination 143.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)15.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 3B and 4Day 85 Post Vaccination 159.167 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1541.944 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1616.429 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1401.563 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1532.813 SFU/million cells
Stage 1 (Naïve) Group 1Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1656.111 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1576.000 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1500.750 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1641.250 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1610.556 SFU/million cells
Stage 1 (Naïve) Group 3AMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 11038.438 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1510.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1360.938 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1360.625 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1492.813 SFU/million cells
Stage 1 (Naïve) Group 3BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1424.063 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1452.500 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1245.833 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1399.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1390.000 SFU/million cells
Stage 1 (Naïve) Group 4Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1670.000 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1423.333 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1405.833 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1418.056 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1305.278 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1466.667 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1625.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1667.14 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1391.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1497.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1475.83 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 1849.38 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 1807.92 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1407.14 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 1717.50 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 1775.71 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 1 Pre-Vaccination 1855.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 85 Post Vaccination 170.00 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 15 Post Vaccination 12131.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 29 Post vaccination 13036.25 SFU/million cells
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BMean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15Day 181 Post Vaccination 145.00 SFU/million cells
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools1.837 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.486 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.387 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S13.393 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools1.557 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S21.225 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.761 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike4.618 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.740 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a1.125 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.085 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a11.304 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame1.852 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame5.044 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a4.479 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools10.422 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools8.160 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools8.377 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools5.005 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S118.558 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S213.336 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike31.871 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 pools6.466 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools1.538 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a1.072 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S19.715 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools3.250 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S23.565 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame1.208 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike13.257 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools2.050 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a3.042 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame0.808 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a0.271 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame0.161 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame0.156 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a0.070 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools2.167 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.391 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools1.064 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.341 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S12.534 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S21.361 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike3.895 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools22.599 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools11.987 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a26.108 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S137.991 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools15.392 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S242.650 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame329.048 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike80.641 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools30.663 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a367.540 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame12.384 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a1.724 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.569 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.499 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.657 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools1.934 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools1.158 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools1.144 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.522 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S13.091 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S21.666 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike4.757 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools6.628 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools1.021 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.778 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S18.160 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools1.533 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S22.561 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame1.124 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike10.722 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools1.541 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a2.269 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.438 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a6.348 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame1.264 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame2.151 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a2.972 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools21.391 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools5.901 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools5.602 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools3.856 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S127.292 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S29.458 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike36.750 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools3.361 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools3.736 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a2.124 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S17.645 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools6.043 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S23.324 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame2.597 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike9.936 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools2.342 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a7.390 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame5.252 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a7.095 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame4.728 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame2.279 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a2.156 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools2.156 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools5.175 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S16.298 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S21.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike6.298 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 pools1.550 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools3.485 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a3.404 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S15.534 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools5.534 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S23.485 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame4.089 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike8.502 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools1.990 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a8.764 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame3.796 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools1.880 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S11.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S21.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike1.550 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools3.953 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools4.609 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a3.897 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S17.193 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools4.015 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S28.667 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame193.308 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike15.085 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools4.833 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a198.466 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame3.460 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a24.188 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame9.699 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame4.304 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a10.186 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools10.869 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools8.758 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools6.204 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools10.498 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S119.626 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S216.702 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike36.328 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools2.935 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools1.938 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a2.622 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S13.605 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools2.716 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S22.072 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame2.692 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike4.644 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools2.072 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a6.452 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame3.205 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a3.088 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame3.558 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame1.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a1.909 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools1.550 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools3.376 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools1.990 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools2.757 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S13.376 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S22.757 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike5.100 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools109.721 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools31.072 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a21.312 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S1208.869 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools99.148 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S2118.209 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame10.427 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike327.078 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools87.137 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a49.390 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame17.651 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a39.339 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame5.290 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame16.898 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a17.151 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools24.202 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools18.059 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools35.403 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools17.899 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S142.261 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S253.302 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike95.564 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 pools24.703 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools32.809 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a15.310 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S149.324 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools24.621 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S258.201 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame5.648 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike107.524 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools25.392 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a34.713 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame13.754 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a42.267 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame18.749 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame11.485 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a12.042 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools31.098 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools20.411 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools24.891 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools31.035 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S151.509 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S255.926 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike107.435 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools41.112 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools16.322 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a32.492 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S148.035 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools6.923 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S234.309 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame956.979 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike82.343 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools17.987 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a994.717 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame5.246 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a31.671 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame11.715 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame10.155 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a9.801 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools25.725 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools12.611 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools21.148 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools16.493 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S138.335 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S237.641 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike75.976 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools129.978 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools51.847 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a26.168 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S1214.659 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools87.681 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S2143.474 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame16.116 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike358.132 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools91.627 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a57.817 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame15.533 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a50.703 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame15.847 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame19.297 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a15.559 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools732.268 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools755.178 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools727.250 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools689.798 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S11487.446 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S21417.047 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike2904.493 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.176 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S10.492 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.492 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S20.176 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.128 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike0.656 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a0.174 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.084 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a0.097 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.082 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.053 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.131 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.120 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S10.131 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S20.120 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike0.226 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S10.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools0.047 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S20.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike0.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a0.038 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S10.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S20.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike0.038 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S10.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S20.082 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame36.585 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike0.082 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.082 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a36.585 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a0.493 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.299 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.063 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.186 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.126 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.601 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.075 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.260 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S10.708 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S20.315 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike1.024 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.059 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S10.097 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.076 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S20.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.109 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike0.097 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a0.098 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame0.047 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools0.052 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools0.038 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools0.056 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S10.052 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S20.056 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike0.071 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools17.145 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools7.229 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a6.100 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S135.990 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools18.845 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S216.941 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame6.784 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike52.931 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools9.712 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a21.729 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame8.845 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a58.926 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame12.990 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame27.390 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a18.547 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools72.302 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools35.237 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools44.250 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools27.882 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S1107.539 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1S272.131 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1Spike179.671 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean 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 pools18.952 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools7.486 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a6.162 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S127.501 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools8.549 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S216.770 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame7.971 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike44.271 pg/mL
Stage 1 (Naïve) Group 1Mean 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 pools9.284 pg/mL
Stage 1 (Naïve) Group 1Mean 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 3a19.533 pg/mL
Stage 1 (Naïve) Group 1Mean 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 Frame5.400 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a10.056 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame3.213 pg/mL
Stage 1 (Naïve) Group 3AMean 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 Frame4.853 pg/mL
Stage 1 (Naïve) Group 3AMean 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 3a1.989 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools13.546 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools5.384 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools7.804 pg/mL
Stage 1 (Naïve) Group 3AMean 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 pools5.214 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S118.930 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)S213.018 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)Spike31.948 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools167.163 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools123.765 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a300.416 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S1312.503 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools145.340 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S2414.445 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame1861.230 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike726.948 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools290.681 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a2290.337 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame128.731 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a10.371 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame3.194 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame3.744 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a3.433 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools10.697 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools5.505 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools6.443 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools6.927 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S116.202 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1S213.370 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1Spike29.572 pg/mL
Secondary

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.

ArmMeasureGroupValue (MEAN)
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools14.317 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools10.754 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame10.909 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S142.900 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools30.201 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S225.071 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame7.161 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike67.971 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools12.700 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a25.493 pg/mL
Stage 1 (Naïve) Group 1Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a7.423 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a48.272 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs Spanning Membrane Frame11.752 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPa Spanning Nucleocapsid Frame20.224 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 115mer OLPs spanning Open Reading Frame 3a16.296 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools209.438 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools96.215 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools71.193 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S1305.653 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1S2140.002 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Spike445.655 pg/mL
Stage 1 (Naïve) Group 3AMean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools68.809 pg/mL
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)75 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)50 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 29 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 85 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)33 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)33 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 29 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 57 Post vaccination 10 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 85 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)33 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination86 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)75 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)60 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 1Percent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent 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 15Day 85 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 1Percent 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 15Day 29 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3APercent 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 15Day 29 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3APercent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent 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 15Day 85 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 3BPercent 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 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 4Percent 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 15Day 29 Post Vaccination90 percentage of participants
Stage 1 (Naïve) Group 4Percent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 29 Post Vaccination86 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post Vaccination86 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 29 Post Vaccination100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 29 Post Vaccination 1100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 394 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 29 Post Vaccination 167 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 209 Post Vaccination 1 (181 Days Post Vaccination 2)50 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)33 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 29 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 57 Post vaccination 10 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 85 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)17 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)17 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)0 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 29 Post Vaccination 1100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 57 Post vaccination 167 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 265 Post Vaccination 1 (181 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 85 Post Vaccination 10 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 169 Post Vaccination 1 (85 Days Post Vaccination 2)100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4Day 99 Post Vaccination 1 (15 Days Post Vaccination 2)100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 1Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3APercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 3BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 1 (Naïve) Group 4Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 366 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 181 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 15 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 85 Post Vaccination100 percentage of participants
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15Day 29 Post Vaccination100 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 1 Pre-Vaccination25 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 29 Post Vaccination 175 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)75 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 1 Pre-Vaccination50 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 29 Post Vaccination 150 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)50 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination89 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination70 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination80 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination80 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination63 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination100 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination38 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination56 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination80 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination70 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination67 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination67 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination57 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination86 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination50 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination50 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 3ADay 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 3ADay 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)25 percent of responders
Stage 1 (Naïve) Group 3APercent 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 3ADay 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 3ADay 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent 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 3ADay 57 Post vaccination 1 (29 Days Post Vaccination 2)0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 4Day 1 Pre-Vaccination1 percent of responders
Stage 1 (Naïve) Group 3APercent 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 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent 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 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination13 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination20 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination11 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination13 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination20 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination14 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination13 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination10 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination11 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination13 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination20 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination14 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination13 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 1Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 99 Post vaccination 1 (15 Days Post Vaccination 2)0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 29 Post Vaccination 10 percent of responders
Stage 1 (Naïve) Group 3APercent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4Day 85 Post Vaccination 10 percent of responders
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1 (Naïve) Group 1Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 1Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3APercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 1 Pre-Vaccination13 percent of responders
Stage 1 (Naïve) Group 3BPercent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 1 (Naïve) Group 4Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 5Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After EUA/Licensed mRNA COVID-19 Vaccines) Group 6Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 15 Post-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 9Percent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 1 Pre-Vaccination0 percent of responders
Stage 2 (SAM-S-TCE Boosts After Approved/Licensed mRNA COVID-19 Vaccines) Group 10A,BPercent 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 15Day 15 Post-Vaccination0 percent of responders

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026