COVID-19
Conditions
Keywords
Heterologous Nonvariant Boost, SARS-COV-2, SARS-COV-2 Vaccine
Brief summary
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (\>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines (mRNA-1273, and mRNA-1273.211 manufactured by ModernaTX, Inc.; BNT162b2 manufactured by Pfizer/BioNTech; or Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & Johnson). This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites. This study includes two cohorts. Cohort 1 will include approximately 880 individuals (50 subjects/group; Groups 1E-11E) greater than 18 years of age and older, stratified into two age strata (18-55 years and \>/=56 years) who previously received COVID-19 vaccine at Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100 mcg dose, two vaccinations of BNT162b2 at the 30 mcg dose, or one vaccination of Ad26.COV2.S at the 5x10\^10 vp dose). Groups 15E-17E will enroll 60 subjects, split (approximately evenly) between age strata as able. Those subjects will be offered enrollment into this study \>/=12 weeks after they received the last dose of their EUA vaccine. Subjects will receive a single open-label intramuscular (IM) injection of the designated delayed booster vaccine and will be followed through 12 months after vaccination: 1) Group 1E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp followed by a 100-mcg dose of mRNA-1273, Group 4E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 7E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp followed by a 30-mcg dose of BNT162b2, Group 10E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp followed by a 100-mcg dose of mRNA-1273.211; Group 12E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp followed by a 50-mcg dose of mRNA-1273; Group 15E - previously EUA-dosed vaccination with Janssen (two doses for Group 15E) - Ad26.COV2.S at 5x1010 vp followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV-2 rS vaccine with 50 mcg Matrix-M); 2) Group 2E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 100-mcg dose of mRNA-1273, Group 5E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 8E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 13E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 50-mcg dose of mRNA-1273; Group 16E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M); 3) Group 3E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273. Group 6E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 9E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 11E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273.211. Group 14E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 50-mcg dose of mRNA-1273, Group 17E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M). A telephone visit will occur one week after each primary EUA vaccination and one week after the booster dose. In person follow-up visits will occur on 14 days following completion of EUA vaccinations and on days 14, and 28 days after the booster dose, as well as 3, 6, and 12 months post the booster vaccination. Additional pools of subjects can be included if needed as additional COVID-19 vaccines are awarded EUA. The primary objectives of this study are 1) to evaluate the safety and reactogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines, and 2) to evaluate the breadth of the humoral immune responses of heterologous and homologous delayed boost regimens following EUA dosing.
Detailed description
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (\>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines (mRNA-1273, and mRNA-1273.211 manufactured by ModernaTX, Inc.; BNT162b2 manufactured by Pfizer/BioNTech; or Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & Johnson). This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites. This study includes two cohorts. Cohort 1 will include approximately 880 individuals (50 subjects/group; Groups 1E-14E, and 60 subjects/group; Groups 15E-17E) greater than 18 years of age and older, stratified into two age strata (18-55 years and \>/=56 years) who previously received COVID-19 vaccine at Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100 mcg dose, two vaccinations of BNT162b2 at the 30 mcg dose, or one vaccination of Ad26.COV2.S at the 5x10\^10 vp dose). Groups 15E-17E will enroll 60 subjects, split (approximately evenly) between age strata as able. Those subjects will be offered enrollment into this study \>/=12 weeks after they received the last dose of their EUA vaccine. Subjects will receive a single open-label intramuscular (IM) injection of the designated delayed booster vaccine and will be followed through 12 months after vaccination: 1) Group 1E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp followed by a 100-mcg dose of mRNA-1273, Group 4E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 7E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp followed by a 30-mcg dose of BNT162b2, Group 10E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp followed by a 100-mcg dose of mRNA-1273.211; Group 12E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp followed by a 50-mcg dose of mRNA-1273; Group 15E - previously EUA-dosed vaccination with Janssen (two doses for Group 15E) - Ad26.COV2.S at 5x1010 vp followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV-2 rS vaccine with 50 mcg Matrix-M); 2) Group 2E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 100-mcg dose of mRNA-1273, Group 5E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 8E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 13E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 50-mcg dose of mRNA-1273; Group 16E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M); 3) Group 3E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273. Group 6E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 5x10\^10 vp dose of Ad26.COV2.S, Group 9E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 11E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273.211. Group 14E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 50-mcg dose of mRNA-1273, Group 17E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M). A telephone visit will occur at Day 8 and in-person follow-up visits will occur on Days 15 and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 250 participants per group aged \>/=18 years of age who have not received a Coronavirus Disease 2019 (COVID-19) vaccine and have no known history of Coronavirus Disease 2019 (COVID-19) or SARS Coronavirus 2 (SARS-CoV-2) infection. They will be assigned to receive COVID-19 vaccine under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval). These pools of participants will be assigned 50 mcg mRNA-1273 at a minimum of 12 weeks following receipt of EUA dosing and followed through 12 months after the last vaccination. A telephone visit will occur one week after each primary EUA vaccination and one week after the booster dose. In person follow-up visits will occur on 14 days following completion of EUA vaccinations and on days 14, and 28 days after the booster dose, as well as 3, 6, and 12 months post the booster vaccination. Additional pools of subjects can be included if needed as additional COVID-19 vaccines are awarded EUA. New groups may be added to Cohort 1 or 2 dependent upon manufacture of variant lineage spike protein-based vaccine constructs or vaccines newly awarded EUA. The primary objectives of this study are 1) to evaluate the safety and reactogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines, and 2) to evaluate the breadth of the humoral immune responses of heterologous and homologous delayed boost regimens following EUA dosing.
Interventions
BIOLOGICALAd26.COV2.S
Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-ß-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
BIOLOGICALBNT162b2
A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
BIOLOGICALmRNA-1273
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). Doses are either 0.25 mL or 0.5 mL.
BIOLOGICALmRNA-1273.211
Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
BIOLOGICALmRNA-1273.222
Formulated in the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
BIOLOGICALSARS-CoV-2 rS/M1
SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
study sites will administer product to which they have been assigned
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria to be eligible to participate in this study: 1. Individuals \>/= 18 years of age at the time of consent. 2. Received and completed primary mRNA COVID-19 vaccine under EUA dosing guidelines and one or two doses of Ad26.COV2.S at least 12 weeks prior to enrollment (Cohort 1 only). 3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures. 4. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health.\* \* Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 5. Female participants of childbearing potential may be enrolled in the study, if all of the following apply: * Practiced adequate contraception for 28 days prior to the first dose of vaccine (Day 1), * Has agreed to continue adequate contraception through 3 months following the booster dose, * Has a negative pregnancy test at screening and on the day of the first study vaccine dose (Day 1), * Is not currently breastfeeding.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study: 1. Known history of SARS-CoV-2 infection. (for Cohort 1 and the primary series of Cohort 2). 2. Prior administration of an investigational coronavirus (SARS Coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV)) vaccine or SARS Coronavirus 2 (SARS-CoV-2) monoclonal antibody in the preceding 90 days or current/planned simultaneous participation in another interventional study. 3. Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2 only). 4. A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles. 5. Receipt of any investigational study product within 28 days prior to enrollment. 6. Received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine). 7. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws, or previously experienced thrombosis with thrombocytopenia (TTS) or heparin-induced thrombocytopenia. 8. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. 9. Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids \>/= 20 milligram per day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Day 1. 10. Received immunoglobulin, blood-derived products, within 90 days prior to first study vaccination. 11. An immediate family member or household member of this study's personnel. 12. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as \>/= 38.0 degrees Celsius or 100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated). |
| Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean AUC of Antibody Against B.1.351 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean AUC of Antibody Against BA.1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean AUC of Antibody Against BA.5 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. |
| Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean of Pseudovirus Neutralization against D614G |
| Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean of Pseudovirus Neutralization against B.1.351 |
| Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean of Pseudovirus Neutralization against B.1.617.2 |
| Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Geometric Mean of Pseudovirus Neutralization against B.1.1.529 |
| Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean of Pseudovirus Neutralization against D614G |
| Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean of Pseudovirus Neutralization against BA.1 |
| Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean of Pseudovirus Neutralization against BA.4/5 |
| Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Geometric Mean of Pseudovirus Neutralization against XBB.1 |
| Frequency of Any Unsolicited Adverse Events (AEs) | Day 1 through Day 29 for Cohort 1, 28 days post any vaccination in Cohort 2 | Number of participants who experienced any unsolicited AEs through 28 days post vaccination |
| Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.1.529 |
| Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590 | Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes. |
| Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590 | Number of participants that experienced any NOCMCs during the course of the study |
| Number of Participants With Any Medically-attended Adverse Events (MAAEs) | For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590 | Number of participants that experienced MAAEs during the course of the study. |
| Frequency of Any Serious Adverse Events (SAEs) | For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590 | 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 lifethreatening 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 Cohort 1, and through 7 days post any vaccination for Cohort 2 | 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 Cohort 1, and through 7 days post any vaccination for Cohort 2 | 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. |
| Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P |
| Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P |
| Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.617.2 S2-P |
| Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.1.529 S2-P |
| Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2 | Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P |
| Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2 | Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.1 S2-P |
| Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2 | Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2 | Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.5 S2-P |
| Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G |
| Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15, Day 29, Day 91, Day 181, Day 273, Day 366 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351 |
| Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15, Day 29 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.617.2 |
| Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 43 Post-Dose 1, Day 15 Post Booster Dose 1 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G |
| Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 43 Post-Dose 1, Day 15 Post Booster Dose 1 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.1 |
| Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 43 Post-Dose 1, Day 15 Post Booster Dose 1 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.4/5 |
| Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 43 Post-Dose 1, Day 15 Post Booster Dose 1 | Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against XBB.1 |
Countries
United States
Participant flow
Recruitment details
Participants that enrolled in Cohort 1 Group 4E and then rolled over into Cohort 1 Group 15E signed separate informed consent documents prior to successful enrollment in each group. Cohort 1Group 15E referred to as Co 1 Gr 15E below.
Pre-assignment details
Cohort 1 provided rapid information about the safety, reactogenicity, and immunogenicity of delayed boost in a previously EUA-dosed group. Cohort 2 was an adaptive cohort that was vaccine-naïve that evaluated the safety, reactogenicity and immunogenicity of EUA-dosed vaccine followed by delayed boost.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 53 |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 51 |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 50 |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL. | 50 |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL. | 49 |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL. | 51 |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL). | 53 |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL). | 51 |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL). | 50 |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL). | 43 |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL). | 50 |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 47 |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 50 |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). | 46 |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant) | 20 |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant) | 16 |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant) | 31 |
| Cohort 2 Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. | 106 |
| Total | 867 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Cohorts Except 15E | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| All Cohorts Except 15E | Became ineligible after enrollment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| All Cohorts Except 15E | Cohort 1 group 4E Participant rolled over into Cohort 1 group 15E | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| All Cohorts Except 15E | Confirmed SARS CoV-2 infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| All Cohorts Except 15E | Death | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| All Cohorts Except 15E | Lost to Follow-up | 0 | 0 | 1 | 2 | 4 | 1 | 0 | 1 | 2 | 2 | 2 | 4 | 2 | 2 | 0 | 5 | 5 | 28 |
| All Cohorts Except 15E | Participant relocated, no follow-up planned | 2 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| All Cohorts Except 15E | Participant unable to adhere to visit schedule | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| All Cohorts Except 15E | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| All Cohorts Except 15E | Withdrawal by Subject | 1 | 1 | 2 | 5 | 2 | 3 | 3 | 1 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 1 | 3 | 16 |
| Direct Enroll, Rollover to Co 1 Gr 15E | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Cohort 2 | Total | Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous All Cohorts except 15E | 56.8 years STANDARD_DEVIATION 14.5 | 53.1 years STANDARD_DEVIATION 16.2 | 54.8 years STANDARD_DEVIATION 17.4 | 50.1 years STANDARD_DEVIATION 13.9 | 49.9 years STANDARD_DEVIATION 16.8 | 50.3 years STANDARD_DEVIATION 15.4 | 47.7 years STANDARD_DEVIATION 14.5 | 54.3 years STANDARD_DEVIATION 16.8 | 50.4 years STANDARD_DEVIATION 17.9 | 49.4 years STANDARD_DEVIATION 13.6 | 48.3 years STANDARD_DEVIATION 16.8 | 48.3 years STANDARD_DEVIATION 13.4 | 52.9 years STANDARD_DEVIATION 17.2 | 47.8 years STANDARD_DEVIATION 16.4 | 48.4 years STANDARD_DEVIATION 14.7 | 43.2 years STANDARD_DEVIATION 11.9 | 39.5 years STANDARD_DEVIATION 13.6 | 49.3 years STANDARD_DEVIATION 16 | — |
| Age, Continuous Cohort 1 Group 15E | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 50.3 years STANDARD_DEVIATION 15.9 | 50.3 years STANDARD_DEVIATION 15.9 |
| BMI All Cohorts except 15E | 28.30 kg/m2 STANDARD_DEVIATION 7.94 | 28.34 kg/m2 STANDARD_DEVIATION 6.1 | 28.79 kg/m2 STANDARD_DEVIATION 7.45 | 27.32 kg/m2 STANDARD_DEVIATION 5.55 | 27.97 kg/m2 STANDARD_DEVIATION 6.4 | 27.58 kg/m2 STANDARD_DEVIATION 5.06 | 26.57 kg/m2 STANDARD_DEVIATION 7.64 | 27.71 kg/m2 STANDARD_DEVIATION 5.21 | 27.76 kg/m2 STANDARD_DEVIATION 6.67 | 26.96 kg/m2 STANDARD_DEVIATION 5.02 | 27.02 kg/m2 STANDARD_DEVIATION 6.61 | 27.01 kg/m2 STANDARD_DEVIATION 4.97 | 26.37 kg/m2 STANDARD_DEVIATION 5.53 | 27.13 kg/m2 STANDARD_DEVIATION 6.08 | 26.62 kg/m2 STANDARD_DEVIATION 4.21 | 31.66 kg/m2 STANDARD_DEVIATION 7.73 | 30.36 kg/m2 STANDARD_DEVIATION 7.52 | 27.99 kg/m2 STANDARD_DEVIATION 6.54 | — |
| BMI Cohort 1 Group 15E | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 29.60 kg/m2 STANDARD_DEVIATION 5.84 | 29.60 kg/m2 STANDARD_DEVIATION 5.84 |
| Ethnicity (NIH/OMB) All Cohorts Except 15E Hispanic or Latino | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 41 Participants | — |
| Ethnicity (NIH/OMB) All Cohorts Except 15E Not Hispanic or Latino | 49 Participants | 46 Participants | 47 Participants | 47 Participants | 49 Participants | 48 Participants | 51 Participants | 50 Participants | 45 Participants | 42 Participants | 47 Participants | 46 Participants | 48 Participants | 45 Participants | 14 Participants | 27 Participants | 101 Participants | 802 Participants | — |
| Ethnicity (NIH/OMB) All Cohorts Except 15E Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants | — |
| Ethnicity (NIH/OMB) Cohort 1 Group 15E Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Cohort 1 Group 15E Not Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 17 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Cohort 1 Group 15E Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 1 Participants | 1 Participants |
| Height All Cohorts except 15E | 170.595 cm STANDARD_DEVIATION 10.875 | 168.104 cm STANDARD_DEVIATION 10.253 | 169.330 cm STANDARD_DEVIATION 10.421 | 171.636 cm STANDARD_DEVIATION 10.273 | 172.547 cm STANDARD_DEVIATION 9.613 | 170.231 cm STANDARD_DEVIATION 10.639 | 171.604 cm STANDARD_DEVIATION 9.582 | 170.448 cm STANDARD_DEVIATION 9.331 | 171.115 cm STANDARD_DEVIATION 9.965 | 171.344 cm STANDARD_DEVIATION 9.844 | 172.266 cm STANDARD_DEVIATION 10.431 | 173.072 cm STANDARD_DEVIATION 10.633 | 169.714 cm STANDARD_DEVIATION 11.691 | 169.990 cm STANDARD_DEVIATION 8.949 | 172.038 cm STANDARD_DEVIATION 10.676 | 170.835 cm STANDARD_DEVIATION 10.766 | 171.326 cm STANDARD_DEVIATION 10.134 | 170.927 cm STANDARD_DEVIATION 10.203 | — |
| Height Cohort 1 Group 15E | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 172.151 cm STANDARD_DEVIATION 6.268 | 172.151 cm STANDARD_DEVIATION 6.268 |
| Race/Ethnicity, Customized All Cohorts Except 15E American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Asian | 4 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants | 7 Participants | 4 Participants | 7 Participants | 0 Participants | 4 Participants | 1 Participants | 62 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Black or African American | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants | 1 Participants | 5 Participants | 10 Participants | 32 Participants | 67 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Multi-Racial | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 31 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | — |
| Race/Ethnicity, Customized All Cohorts Except 15E White | 46 Participants | 41 Participants | 43 Participants | 44 Participants | 43 Participants | 40 Participants | 51 Participants | 47 Participants | 43 Participants | 38 Participants | 37 Participants | 40 Participants | 37 Participants | 35 Participants | 10 Participants | 15 Participants | 70 Participants | 680 Participants | — |
| Race/Ethnicity, Customized Cohort 1 Group 15E American Indian or Alaska Native | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Asian | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Black or African American | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Multi-Racial | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E Other | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Cohort 1 Group 15E White | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 13 Participants | 13 Participants |
| Sex: Female, Male All Cohorts Except 15E Female | 26 Participants | 32 Participants | 29 Participants | 27 Participants | 16 Participants | 23 Participants | 29 Participants | 26 Participants | 23 Participants | 22 Participants | 23 Participants | 21 Participants | 24 Participants | 27 Participants | 6 Participants | 16 Participants | 55 Participants | 425 Participants | — |
| Sex: Female, Male All Cohorts Except 15E Male | 27 Participants | 19 Participants | 21 Participants | 23 Participants | 33 Participants | 28 Participants | 24 Participants | 25 Participants | 27 Participants | 21 Participants | 27 Participants | 26 Participants | 26 Participants | 19 Participants | 10 Participants | 15 Participants | 51 Participants | 422 Participants | — |
| Sex: Female, Male Cohort 1 Group 15E Female | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 9 Participants | 9 Participants |
| Sex: Female, Male Cohort 1 Group 15E Male | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 11 Participants | 11 Participants |
| Weight All Groups Except 15E | 82.474 kg STANDARD_DEVIATION 22.586 | 79.960 kg STANDARD_DEVIATION 17.572 | 82.877 kg STANDARD_DEVIATION 23.87 | 80.705 kg STANDARD_DEVIATION 18.437 | 83.536 kg STANDARD_DEVIATION 20.798 | 80.229 kg STANDARD_DEVIATION 17.936 | 78.743 kg STANDARD_DEVIATION 24.71 | 80.766 kg STANDARD_DEVIATION 17.668 | 80.935 kg STANDARD_DEVIATION 18.56 | 79.649 kg STANDARD_DEVIATION 18.894 | 80.050 kg STANDARD_DEVIATION 19.014 | 81.383 kg STANDARD_DEVIATION 18.374 | 76.205 kg STANDARD_DEVIATION 18.407 | 78.521 kg STANDARD_DEVIATION 18.593 | 79.03 kg STANDARD_DEVIATION 14.6 | 93.17 kg STANDARD_DEVIATION 26.77 | 88.771 kg STANDARD_DEVIATION 21.467 | 81.935 kg STANDARD_DEVIATION 20.458 | — |
| Weight Cohort 1 Group 15E | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 88.15 kg STANDARD_DEVIATION 20.08 | 88.15 kg STANDARD_DEVIATION 20.08 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 1 / 51 | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 51 | 0 / 52 | 0 / 51 | 0 / 50 | 0 / 43 | 0 / 50 | 0 / 47 | 0 / 50 | 0 / 46 | 0 / 20 | 0 / 16 | 0 / 31 | 0 / 106 |
| other Total, other adverse events | 49 / 53 | 49 / 51 | 50 / 50 | 46 / 50 | 46 / 49 | 47 / 51 | 52 / 52 | 50 / 51 | 50 / 50 | 43 / 43 | 48 / 50 | 46 / 47 | 49 / 50 | 46 / 46 | 18 / 20 | 12 / 16 | 27 / 31 | 100 / 106 |
| serious Total, serious adverse events | 2 / 53 | 4 / 51 | 0 / 50 | 1 / 50 | 1 / 49 | 2 / 51 | 1 / 52 | 1 / 51 | 0 / 50 | 0 / 43 | 2 / 50 | 1 / 47 | 1 / 50 | 1 / 56 | 0 / 20 | 0 / 16 | 1 / 31 | 5 / 106 |
Outcome results
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: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 6 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 3 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 3 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 4 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 3 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
Primary
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
Time frame: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 2 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 1 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 1 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 1 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 1 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 2 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 2 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 1 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | 5 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 lifethreatening 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: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 2 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 4 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Any Serious Adverse Events (SAEs) | 2 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Any Serious Adverse Events (SAEs) | 2 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Any Serious Adverse Events (SAEs) | 5 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 Cohort 1, 28 days post any vaccination in Cohort 2
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 28 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 29 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 31 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Any Unsolicited Adverse Events (AEs) | 31 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Any Unsolicited Adverse Events (AEs) | 28 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Any Unsolicited Adverse Events (AEs) | 28 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Any Unsolicited Adverse Events (AEs) | 28 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Any Unsolicited Adverse Events (AEs) | 29 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Any Unsolicited Adverse Events (AEs) | 24 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Any Unsolicited Adverse Events (AEs) | 22 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Any Unsolicited Adverse Events (AEs) | 24 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 20 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 30 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Any Unsolicited Adverse Events (AEs) | 25 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Any Unsolicited Adverse Events (AEs) | 8 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Any Unsolicited Adverse Events (AEs) | 6 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Any Unsolicited Adverse Events (AEs) | 14 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Any Unsolicited Adverse Events (AEs) | 60 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 Cohort 1, and through 7 days post any vaccination for Cohort 2
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 41 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 44 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 41 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 38 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 35 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 35 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 48 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 39 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 45 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 39 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 45 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 42 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 41 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 40 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 11 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 5 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 16 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Local Solicited Reactogenicity Adverse Events (AEs) | 94 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 Cohort 1, and through 7 days post any vaccination for Cohort 2
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 38 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 47 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 45 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 39 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 42 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 42 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 39 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 38 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 46 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 37 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 38 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 41 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 42 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 40 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 17 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 10 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 23 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs) | 93 Participants |
Primary
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 3412.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 7269.52 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 17068.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 2707.32 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 355.20 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 7586.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 6123.52 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 18723.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 9039.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 31782.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 27187.51 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 10520.02 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 15312.25 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 6807.45 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 2749.80 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 1965.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 5675.43 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 6123.72 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 2515.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 350.87 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 1183.72 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 13092.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 19054.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 12819.14 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 15698.38 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 3749.08 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 14026.72 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 12658.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 2052.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 11973.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 8225.58 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 9858.05 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 7831.52 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 4637.99 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 16188.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 9769.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 502.26 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 7249.59 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 4250.72 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 11132.59 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 9622.02 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 19202.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 30886.55 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 4295.75 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 11306.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 13491.41 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 11526.24 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 1860.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 10021.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 21838.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 8133.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 6073.64 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 484.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 22297.06 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 9632.54 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 6689.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 11695.26 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 13184.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 36401.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 20953.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 18446.49 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 2128.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 10433.04 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 309.27 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 5942.40 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 18673.13 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 7344.94 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 3979.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 8475.77 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 2525.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 22018.09 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 12926.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 34724.95 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 16035.47 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 17580.65 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 19275.37 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 1579.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 12677.50 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 12045.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 33890.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 16727.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 7339.99 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 9499.76 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 504.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 5968.57 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 3184.43 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 4536.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 5164.32 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 3595.20 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 11849.54 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 13423.41 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 21524.83 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 17202.81 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 17215.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 14911.93 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 15484.34 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 1, Pre-Dose | 3106.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 9530.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 9291.17 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 13089.37 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 16656.77 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 13220.17 Arbitrary Unit*1/dilution |
Primary
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 11447.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 19450.29 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 32520.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 10642.97 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 1396.82 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 19755.04 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 14461.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 31822.66 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 21327.55 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 42841.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 40054.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 24372.65 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 29761.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 19310.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 7615.66 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 6193.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 17076.66 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 18956.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 8068.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 1422.80 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 4208.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 32534.84 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 35454.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 31914.57 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 33090.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 10772.57 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 33290.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 27283.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 6473.05 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 30280.41 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 24178.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 24769.12 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 23385.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 14704.04 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 31272.17 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 26161.22 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 1894.19 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 18843.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 12437.92 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 26060.07 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 23258.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 33605.00 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 43721.86 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 12682.79 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 24536.98 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 26048.76 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 27094.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 6603.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 23893.33 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 34878.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 18216.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 16703.38 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 1730.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 36782.02 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 23195.15 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 19131.14 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 28150.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 28966.27 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 48350.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 36714.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 36376.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 6229.00 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 25309.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 1107.26 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 17723.13 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 33526.55 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 19848.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 13553.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 22608.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 7371.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 37238.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 29076.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 45935.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 31957.12 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 35405.05 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 36641.95 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 4897.12 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 30020.08 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 27851.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 45352.29 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 35118.48 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 21955.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 26576.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 2690.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 17186.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 9451.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 14585.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 14825.07 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 11890.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 28431.40 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 32425.08 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 41302.86 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 37407.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 38608.31 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 32383.00 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 34856.19 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 1, Pre-Dose | 10063.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 23753.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 24213.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 29771.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 35909.49 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 30940.18 Arbitrary Unit*1/dilution |
Primary
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 44367.39 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 15 | 365421.15 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 29 | 260668.10 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 91 | 178509.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2 | Day 181 | 92349.30 Arbitrary Unit*1/dilution |
Primary
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.5 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 48314.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | Day 15 | 409932.34 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | Day 29 | 297241.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | 4Day 91 | 215637.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2 | Day 181 | 128920.81 Arbitrary Unit*1/dilution |
Primary
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 193349.76 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 15 | 1201152.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 29 | 921655.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 91 | 688925.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2 | Day 181 | 445271.64 Arbitrary Unit*1/dilution |
Primary
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated).
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 17458.61 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 31618.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 16279.54 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 46396.64 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 2940.97 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 47163.57 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 32351.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 30329.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 58170.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 26101.97 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 28690.99 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 53826.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 14223.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 33164.24 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 42511.10 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 12896.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 8387.48 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 11221.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 2926.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 26224.15 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 24139.14 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 20715.09 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 46337.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 47342.92 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 51277.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 45772.37 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 49339.52 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 41154.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 39977.61 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 11549.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 34368.23 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 35430.22 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 41335.27 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 3790.32 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 34832.97 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 42955.92 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 20331.28 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 28807.64 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 19889.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 48358.86 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 58564.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 23437.84 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 37066.79 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 37981.19 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 34556.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 33341.39 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 47695.55 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 11448.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 38564.83 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 36487.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 28640.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 27894.31 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 25844.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 38505.13 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 34007.68 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 49577.25 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 4198.32 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 38808.82 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 12104.83 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 60745.09 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 48892.87 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 35751.04 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 46309.04 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 2314.29 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 25855.31 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 20954.21 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 46758.48 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 30620.81 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 32151.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 47851.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 59407.62 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 51633.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 45909.39 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 13480.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 42109.89 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 58728.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 8895.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 44965.48 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 36651.20 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 47222.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 40408.83 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 35196.75 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 31119.43 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 15093.62 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 4423.99 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 20826.02 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 20950.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 15 | 22969.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 44220.57 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 46053.86 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 43013.25 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 15 | 50130.93 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 17749.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 49916.77 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 38984.11 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 273 | 30573.66 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 29 | 42857.80 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 181 | 31129.10 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 366 | 37897.76 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 91 | 38320.95 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 1, Pre-Dose | 13682.64 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 | Day 15 | 44295.72 Arbitrary Unit*1/dilution |
Primary
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.351 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 8213.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 15169.94 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 26285.49 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 7471.43 Arbitrary Unit*1/dilution |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 942.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 15948.35 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 11013.62 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 27671.50 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 17151.09 Arbitrary Unit*1/dilution |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 36774.49 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 34955.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 19820.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 26254.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 15594.79 Arbitrary Unit*1/dilution |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 6047.85 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 4374.91 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 13419.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 14562.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 5927.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 954.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 2898.58 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 25606.61 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 28074.29 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 25363.92 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 25421.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 8076.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 26463.44 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 21791.31 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 5201.78 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 24277.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 18677.11 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 19134.05 Arbitrary Unit*1/dilution |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 17961.00 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 11200.14 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 25833.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 21177.37 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 1402.70 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 14117.54 Arbitrary Unit*1/dilution |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 9676.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 20937.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 19035.58 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 27268.18 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 38209.76 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 10079.24 Arbitrary Unit*1/dilution |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 20240.62 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 20818.34 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 22385.67 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 5572.24 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 19883.25 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 30475.16 Arbitrary Unit*1/dilution |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 15227.63 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 13779.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 1157.98 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 30963.49 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 19023.81 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 14797.17 Arbitrary Unit*1/dilution |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 23311.90 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 24867.46 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 42846.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 33082.45 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 31525.58 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 4842.69 Arbitrary Unit*1/dilution |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 21187.80 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 814.66 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 13945.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 26189.91 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 15586.43 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 9654.27 Arbitrary Unit*1/dilution |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 17859.94 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 5850.30 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 33595.91 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 24777.00 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 39348.91 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 28289.22 Arbitrary Unit*1/dilution |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 30792.74 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 31546.58 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 4007.33 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 24443.88 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 23144.27 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 38613.53 Arbitrary Unit*1/dilution |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 29301.54 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 17064.67 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 20832.94 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 1525.71 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 15 | 12221.52 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 6723.73 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 10607.87 Arbitrary Unit*1/dilution |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 10675.96 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 8253.24 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 22911.81 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 26049.67 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 15 | 35359.98 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 30089.60 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 31999.19 Arbitrary Unit*1/dilution |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 26478.42 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 29 | 28612.56 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 1, Pre-Dose | 7414.32 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 181 | 19694.67 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 273 | 19442.79 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 91 | 24620.13 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 15 | 29907.22 Arbitrary Unit*1/dilution |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1 | Day 366 | 25344.25 Arbitrary Unit*1/dilution |
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.1.529
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 102.18 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 36.18 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 240.50 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 6.04 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 31.78 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 73.17 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 705.75 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 28.96 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 100.71 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 533.35 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 232.18 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 648.16 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 353.35 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 14.06 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 72.58 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 108.13 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 203.18 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 7.18 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 11.15 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 223.89 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 76.78 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 20.23 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 26.93 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 483.16 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 20.32 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 480.51 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 459.30 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 499.15 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 180.65 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 364.66 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 123.04 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 358.92 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 229.00 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 14.14 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 566.71 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 339.84 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 80.65 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 575.70 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 9.01 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 238.77 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 63.64 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 241.39 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 157.27 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 159.41 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 23.02 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 499.59 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 183.12 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 140.61 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 239.69 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 170.76 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 324.05 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 442.53 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 15.03 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 131.04 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 493.38 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 464.12 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 217.99 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 835.72 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 150.67 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 136.63 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 9.20 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 395.65 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 952.49 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 368.11 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 15.30 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 222.76 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 254.41 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 1048.01 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 258.14 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 89.71 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 518.33 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 303.22 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 6.14 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 66.61 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 13.94 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 247.05 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 586.83 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 175.75 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 1039.56 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 421.76 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 725.75 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 307.56 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 406.30 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 333.17 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 1052.87 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 10.25 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 1076.92 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 82.90 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 859.98 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 126.81 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 114.81 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 648.36 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 209.59 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 12.67 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 51.38 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 360.07 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 704.28 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 1221.74 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 1307.88 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 749.46 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 589.29 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 366 | 1201.30 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 91 | 627.30 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 15 | 816.04 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 273 | 1012.61 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 29 | 1181.12 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 181 | 753.27 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1 | Day 1, Pre-Dose | 84.06 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.351
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 117.60 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 407.53 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 46.02 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 281.66 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 8.66 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 572.08 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 29.74 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 130.18 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 199.21 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 439.79 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 73.97 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 405.60 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 582.60 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 186.12 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 17.81 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 24.90 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 6.75 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 17.61 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 13.52 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 54.85 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 394.18 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 449.28 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 28.82 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 455.71 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 548.74 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 155.05 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 216.16 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 233.11 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 260.07 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 12.06 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 332.24 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 125.92 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 68.94 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 132.44 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 7.99 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 398.86 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 607.55 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 34.42 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 252.19 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 120.76 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 273.59 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 19.67 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 487.02 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 184.88 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 219.26 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 366 | 490.51 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 430.23 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 126.92 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 8.92 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 362.95 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 273 | 269.32 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 174.12 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 366 | 856.84 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 512.13 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 15.07 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 273 | 513.05 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 899.83 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 343.66 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 197.54 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 105.17 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 275.33 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 7.76 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 69.40 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 673.88 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 451.56 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 327.32 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 1927.07 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 41.70 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 413.72 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 223.86 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 181 | 183.98 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 600.49 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 21.38 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 15 | 1464.22 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 48.11 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 15.60 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 112.57 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 291.20 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 568.68 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 77.29 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 29 | 1040.55 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 1, Pre-Dose | 84.59 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1 | Day 91 | 408.30 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.617.2
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Groups 1E-3E and 10E-11E at Day 29.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 506.87 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 12.02 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 580.05 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 1102.70 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 101.40 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 735.02 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 989.48 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 29.57 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 657.82 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 42.93 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 10.27 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 107.24 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 759.42 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 35.11 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 417.81 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 12.63 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 490.28 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 90.35 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 1525.15 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 34.46 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 907.09 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 383.22 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 15.00 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 48.46 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 1025.81 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 10.76 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 623.94 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 307.44 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 1420.34 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 61.98 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 782.88 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 1, Pre-Dose | 23.83 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 29 | 781.46 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1 | Day 15 | 1399.37 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.1
Time frame: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 1, Pre-Vaccination 1 | 6.36 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 43, Post Vaccination 1 | 189.09 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 15, Post Booster Vaccination 1 | 2680.27 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 679.09 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 15, Post-Booster Vaccination 2 | 12381.92 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 29, Post-Booster Vaccination 2 | 9496.08 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 91, Post-Booster Vaccination 2 | 3272.98 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2 | Day 181, Post-Booster Vaccination 2 | 4076.50 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.4/5
Time frame: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 1, Pre-Vaccination 1 | 7.59 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 43, Post Vaccination 1 | 260.47 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 15, Post Booster Vaccination 1 | 1377.38 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 464.55 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 15, Post-Booster Vaccination 2 | 10328.08 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 29, Post-Booster Vaccination 2 | 7558.08 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 91, Post-Booster Vaccination 2 | 6848.36 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2 | Day 181, Post-Booster Vaccination 2 | 2540.36 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Geometric Mean of Pseudovirus Neutralization against D614G
Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2816.89 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 407.99 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1877.30 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 38.68 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 345.65 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 816.75 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 3758.62 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 800.31 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 378.03 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 2996.19 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1428.84 titer |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 599.64 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 102.44 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 505.67 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1142.14 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 2138.09 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1006.53 titer |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 3246.95 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 120.26 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 848.73 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 129.85 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 122.76 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 31.27 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 219.40 titer |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 807.32 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 2645.09 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 254.91 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 1578.80 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 2107.40 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 1774.79 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 2176.45 titer |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 2659.82 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1090.53 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 894.14 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1982.45 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 76.63 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1419.20 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 999.79 titer |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1459.31 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 293.20 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 572.36 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1480.60 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1001.61 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 39.01 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 598.28 titer |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 1419.60 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1179.14 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 238.04 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2865.92 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 2162.02 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 600.34 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 778.99 titer |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1341.31 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 1806.48 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 476.94 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 88.50 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1358.34 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 992.82 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1305.46 titer |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 845.35 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1686.01 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 560.75 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2232.85 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 689.58 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1413.18 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 26.82 titer |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 683.16 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 658.36 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 66.26 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 3214.54 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 3799.17 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1308.36 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1079.67 titer |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 2068.00 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1787.22 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 538.84 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 396.82 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 805.15 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 21.79 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1337.80 titer |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 1804.29 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 120.75 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 3383.04 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1390.28 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2944.85 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 962.58 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1475.96 titer |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 2597.40 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 3524.38 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1208.81 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1056.44 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 1008.89 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 2612.67 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 55.58 titer |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2778.25 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 73.77 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 619.78 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 650.45 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 499.25 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1070.13 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 305.52 titer |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 509.25 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 373.44 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 2726.20 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 1557.44 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 1978.27 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 2340.64 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2431.34 titer |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1661.39 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 91 | 1741.71 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 366 | 1532.80 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 15 | 2839.93 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 273 | 1364.44 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 29 | 2681.75 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 181 | 1356.53 titer |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1 | Day 1, Pre-Dose | 342.29 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Geometric Mean of Pseudovirus Neutralization against D614G
Time frame: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 1, Pre-Vaccination 1 | 13.23 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 43, Post Vaccination 1 | 4010.57 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 15, Post Booster Vaccination 1 | 7456.62 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 2225.56 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 15, Post-Booster Vaccination 2 | 18927.45 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 29, Post-Booster Vaccination 2 | 17481.83 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 91, Post-Booster Vaccination 2 | 9244.35 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2 | Day 181, Post-Booster Vaccination 2 | 3932.11 titer |
Primary
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against XBB.1
Time frame: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 1, Pre-Vaccination 1 | 5.28 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 43, Post Vaccination 1 | 24.37 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 15, Post Booster Vaccination 1 | 132.74 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 1, Pre-Booster Vaccination 2 | 39.52 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 15, Post-Booster Vaccination 2 | 969.29 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 29, Post-Booster Vaccination 2 | 648.84 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 91, Post-Booster Vaccination 2 | 462.50 titer |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2 | Day 181, Post-Booster Vaccination 2 | 211.99 titer |
Primary
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
Time frame: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 1 Participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 1 Participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 0 Participants |
| Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222) | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | 1 Participants |
Primary
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.1.529
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 65 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 67 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 56 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 31 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 90 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 92 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 51 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 72 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 59 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 78 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 61 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 40 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 52 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 80 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 17 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 76 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 92 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 83 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 77 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 68 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 82 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 88 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 70 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 83 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 76 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 62 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 92 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 76 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 68 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 89 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 52 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 51 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 80 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 66 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 94 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 74 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 74 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 82 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 79 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 97 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 61 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 83 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 92 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 89 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 78 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 66 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 67 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 85 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 93 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 66 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 88 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 85 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 92 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 94 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 96 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 93 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 89 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 93 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 94 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 79 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 89 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 83 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 74 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 68 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 55 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 69 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 82 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 87 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 70 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 86 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 366 | 55 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 15 | 55 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 29 | 66 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 273 | 64 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 181 | 57 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1 | Day 91 | 56 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.1.529 S2-P
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 66 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 75 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 63 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 6 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 28 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 31 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 68 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 92 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 20 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 54 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 50 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 69 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 38 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 87 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 84 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 47 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 63 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 63 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 62 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 53 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 48 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 57 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 55 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 62 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 54 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 94 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 57 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 70 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 38 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 48 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 78 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 49 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 28 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 56 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 79 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 52 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 96 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 77 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 97 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 96 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 85 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 66 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 59 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 70 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 92 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 82 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 91 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 78 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 92 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 57 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 73 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 91 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 72 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 73 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 81 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 63 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 78 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 68 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 84 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 86 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 78 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 36 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 50 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 45 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 60 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 273 | 36 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 29 | 52 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 366 | 50 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 181 | 30 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 91 | 52 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1 | Day 15 | 59 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 85 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 94 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 95 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 65 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 80 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 32 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 95 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 53 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 40 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 56 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 20 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 40 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 80 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 90 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 80 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 79 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 90 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 65 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 95 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 70 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 35 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 85 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 69 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 79 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 77 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 273 | 79 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 366 | 91 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 94 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 273 | 83 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 366 | 93 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 82 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 89 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 75 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 85 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 80 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 59 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 80 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 181 | 65 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 61 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 47 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 64 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 29 | 59 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1 | Day 91 | 52 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 68 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 94 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 75 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 33 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 4 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 16 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 20 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 50 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 76 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 16 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 48 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 50 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 56 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 35 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 87 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 80 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 44 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 46 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 35 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 49 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 34 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 48 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 47 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 43 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 53 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 54 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 84 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 65 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 74 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 96 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 26 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 25 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 43 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 25 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 12 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 46 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 38 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 26 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 72 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 80 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 94 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 76 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 59 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 51 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 70 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 92 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 87 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 94 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 68 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 78 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 43 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 68 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 83 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 63 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 79 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 87 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 63 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 72 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 42 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 15 | 84 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 78 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 78 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 36 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 50 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 45 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 15 | 53 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 273 | 36 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 29 | 52 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 366 | 50 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 181 | 30 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 91 | 48 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1 | Day 15 | 55 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.617.2
Time frame: Day 15, Day 29
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. This assay was not completed for Group 15E, 16E, and 17E.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 94 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 70 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 86 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 56 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 65 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 74 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 96 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 88 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 94 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 92 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 83 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1 | Day 15 | 100 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.617.2 S2-P
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 68 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 96 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 73 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 27 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 2 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 6 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 18 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 40 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 67 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 18 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 46 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 50 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 48 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 31 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 87 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 80 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 31 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 37 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 27 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 38 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 26 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 50 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 51 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 51 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 58 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 51 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 86 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 62 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 64 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 96 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 23 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 25 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 39 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 22 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 12 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 46 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 38 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 28 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 70 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 83 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 93 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 68 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 88 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 88 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 77 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 56 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 49 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 70 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 92 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 91 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 94 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 66 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 71 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 41 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 65 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 66 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 74 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 61 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 65 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 77 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 87 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 58 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 72 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 32 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 68 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 61 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 72 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 36 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 50 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 45 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 53 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 273 | 27 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 29 | 48 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 366 | 40 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 181 | 30 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 91 | 36 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1 | Day 15 | 52 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.1
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 15 Post-Booster Dose 2 | 86 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 29 Post-Booster Dose 2 | 89 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 91 Post-Booster Dose 2 | 59 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 181 Post-Booster Dose 2 | 59 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.1
Time frame: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 43 Post-Dose 1 | 97 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 for Cohort 2 | Day 15 Post Booster Dose 1 | 100 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.1 S2-P
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2 | Day 15 | 79 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2 | Day 29 | 70 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2 | Day 91 | 38 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2 | Day 181 | 19 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.4/5
Time frame: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 43 Post-Dose 1 | 97 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 15 Post Booster Dose 1 | 87 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.4/5
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 15 Post-Booster Dose 2 | 89 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 29 Post-Booster Dose 2 | 89 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 91 Post-Booster Dose 2 | 90 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2 | Day 181 Post-Booster Dose 2 | 48 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.5 S2-P
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2 | Day 15 | 79 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2 | Day 29 | 70 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2 | Day 91 | 45 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2 | Day 181 | 37 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 57 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 73 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 94 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 80 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 14 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 38 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 84 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 42 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 86 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 49 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 57 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 57 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 72 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 80 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 54 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 50 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 44 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 74 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 63 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 64 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 61 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 69 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 73 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 83 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 80 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 82 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 73 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 88 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 78 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 94 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 62 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 84 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 62 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 57 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 28 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 94 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 51 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 61 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 64 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 72 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 77 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 57 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 75 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 83 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 88 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 73 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 78 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 84 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 90 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 95 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 94 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 95 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 91 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 84 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 98 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 98 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 66 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 76 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 83 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 98 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 87 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 100 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 93 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 58 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 72 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 78 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 72 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 53 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 63 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 67 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 60 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 50 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 36 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 45 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 181 | 52 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 15 | 55 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 91 | 52 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 29 | 55 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 273 | 41 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against D614G for Cohort 1 | Day 366 | 50 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 15 Post-Booster Dose 2 | 71 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 29 Post-Booster Dose 2 | 74 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 91 Post-Booster Dose 2 | 45 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 181 Post-Booster Dose 2 | 22 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Time frame: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 43 Post-Dose 1 | 97 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against D614G for Cohort 2 | Day 15 Post Booster Dose 1 | 100 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Time frame: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 56 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 88 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 94 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 65 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 12 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 2 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 6 percentage of participants |
| Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 7 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 26 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 37 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 8 percentage of participants |
| Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 26 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 50 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 46 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 25 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 83 percentage of participants |
| Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 84 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 9 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 14 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 15 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 18 percentage of participants |
| Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 15 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 40 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 45 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 43 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 47 percentage of participants |
| Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 38 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 78 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 51 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 60 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 88 percentage of participants |
| Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 78 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 10 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 11 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 14 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 8 percentage of participants |
| Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 6 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 31 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 26 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 35 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 22 percentage of participants |
| Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 50 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 60 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 90 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 83 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 46 percentage of participants |
| Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 75 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 68 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 46 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 34 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 31 percentage of participants |
| Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 52 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 85 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 86 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 82 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 88 percentage of participants |
| Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 100 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 48 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 55 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 36 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 50 percentage of participants |
| Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 44 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 57 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 70 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 80 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 52 percentage of participants |
| Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 59 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 15 | 58 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 32 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 67 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 47 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 44 percentage of participants |
| Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 61 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 27 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 50 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 36 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 38 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 15 | 47 percentage of participants |
| Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 43 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 15 | 45 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 366 | 35 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 29 | 45 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 91 | 40 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 181 | 26 percentage of participants |
| Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1 | Day 273 | 27 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2 | Day 15 | 61 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2 | Day 29 | 56 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2 | Day 91 | 41 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2 | Day 181 | 26 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against XBB.1
Time frame: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 43 Post-Dose 1 | 47 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 15 Post Booster Dose 1 | 93 percentage of participants |
Primary
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against XBB.1
Time frame: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 29 Post-Booster Dose 2 | 93 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 91 Post-Booster Dose 2 | 79 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 181 Post-Booster Dose 2 | 48 percentage of participants |
| Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) | Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2 | Day 15 Post-Booster Dose 2 | 93 percentage of participants |