COVID-19Phase 1/2NCT04889209

Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines

A Phase 1/2 study testing Ad26.COV2.S, BNT162b2 and mRNA-1273 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Ad26.COV2.S, BNT162b2 and mRNA-1273
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 867 participants
Where: 10 sitesUnited States
Study dates: 28 May 2021to 16 Jun 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be eligible to participate in this study:
Individuals >/= 18 years of age at the time of consent.
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).
Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
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.

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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.

Who cannot join

Participants meeting any of the following criteria will be excluded from the study:
Known history of SARS-CoV-2 infection. (for Cohort 1 and the primary series of Cohort 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.
Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2 only).
A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles.
Receipt of any investigational study product within 28 days prior to enrollment.

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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).
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.
Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition.
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.
Received immunoglobulin, blood-derived products, within 90 days prior to first study vaccination.
An immediate family member or household member of this study's personnel.
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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Maryland Baltimore - Institute of Human Virology
Baltimore, Maryland, 21201-1009
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45206-1613
The Hope Clinic of Emory University
Decatur, Georgia, 30030-1705
University of Texas Medical Branch
Galveston, Texas, 77555-0435
Baylor College of Medicine
Houston, Texas, 77030-3411
NYU Langone Vaccine Center
New York, New York, 10016
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213-3205
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14642
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466
The University of Washington - Virology Research Clinic
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines

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.

Read the detailed description

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.

Conditions: COVID-19
Being tested: Ad26.COV2.S, BNT162b2, mRNA-1273, mRNA-1273.211, mRNA-1273.222
Keywords: Heterologous Nonvariant Boost, SARS-COV-2, SARS-COV-2 Vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ad26.COV2.SBiological
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.
BNT162b2Biological
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).
mRNA-1273Biological
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.
mRNA-1273.211Biological
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).
mRNA-1273.222Biological
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.
SARS-CoV-2 rS/M1Biological
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)

Study groups in NCT04889209
Study group	Role	What they receive
Cohort 1 Group 10E	Experimental	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 (boost dose). N = 50 Receives: Biological: mRNA-1273.211
Cohort 1 Group 11E	Experimental	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 (boost dose). N = 50 Receives: Biological: mRNA-1273.211
Cohort 1 Group 12E	Experimental	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 Receives: Biological: mRNA-1273
Cohort 1 Group 13E	Experimental	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 Receives: Biological: mRNA-1273
Cohort 1 Group 14E	Experimental	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 Receives: Biological: mRNA-1273
Cohort 1 Group 15E	Experimental	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 Receives: Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 16E	Experimental	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 Receives: Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 17E	Experimental	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 Receives: Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 1E	Experimental	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 (boost dose). N = 50 Receives: Biological: mRNA-1273
Cohort 1 Group 2E	Experimental	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 (boost dose). N = 50 Receives: Biological: mRNA-1273
Cohort 1 Group 3E	Experimental	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 (boost dose). N = 50 Receives: Biological: mRNA-1273
Cohort 1 Group 4E	Experimental	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 (boost dose). N = 50 Receives: Biological: Ad26.COV2.S
Cohort 1 Group 5E	Experimental	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 (boost dose). N = 50 Receives: Biological: Ad26.COV2.S
Cohort 1 Group 6E	Experimental	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 (boost dose). N = 50 Receives: Biological: Ad26.COV2.S
Cohort 1 Group 7E	Experimental	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 (boost dose). N = 50 Receives: Biological: BNT162b2
Cohort 1 Group 8E	Experimental	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 (boost dose). N = 50 Receives: Biological: BNT162b2
Cohort 1 Group 9E	Experimental	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 (boost dose). N = 50 Receives: Biological: BNT162b2
Cohort 2	Experimental	A prospective design cohort with naïve to COVID-19 vaccine and infection participants of > / = 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval) followed by a delayed vaccination (50 mcg mRNA-1273) after a minimum of 12 weeks. A second booster (fourth dose) will be administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at a 4-12 month interval N=250 Receives: Biological: mRNA-1273; Biological: mRNA-1273.222

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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.
Measured: 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 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.
Measured: 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 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.
Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against D614G
Measured: 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 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.351
Measured: 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 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.617.2
Measured: 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 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.1.529
Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Geometric Mean of Pseudovirus Neutralization against D614G
Measured: 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 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.1
Measured: 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 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.4/5
Measured: 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 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against XBB.1
Measured: 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
Frequency of Any Unsolicited Adverse Events (AEs)
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
Measured: Day 1 through Day 29 for Cohort 1, 28 days post any vaccination in Cohort 2
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.
Measured: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study
Measured: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
Measured: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
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.
Measured: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
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.
Measured: Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
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.
Measured: Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: 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 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
Measured: 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 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
Measured: 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 Against D614G for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 15, Day 29
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
Measured: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
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
Measured: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
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
Measured: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
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
Measured: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
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
Measured: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
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
Measured: 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 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
Measured: 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 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
Measured: 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 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
Measured: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 202116 Jun 2023

First posted17 May 2021
Study start28 May 2021
Primary completion16 Jun 2023
Study completion16 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 867 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04889209
Sponsor's protocol ID: 21-0012
Other IDs: 5UM1AI148684-02
Status last verified: 8 Jul 2024
First submitted: 13 May 2021
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Atmar RL, Lyke KE, Posavad CM, Deming ME, Brady RC, Dobrzynski D, Edupuganti S, Mulligan MJ, Rupp RE, Rostad CA, Jackson LA, Martin JM, Shriver MC, Rajakumar K, Coler RN, El Sahly HM, Kottkamp AC, Branche AR, Frenck RW, Johnston C, Babu TM, Backer M, Archer JI, Crandon S, Nakamura A, Nayak SU, Szydlo D, Dominguez Islas CP, Brown ER, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Beigel JH, Pasetti M, Roberts PC. Mucosal and Systemic Antibody Responses After Boosting With a Bivalent Messenger RNA Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine. J Infect Dis. 2025 Oct 15;232(4):971-981. doi: 10.1093/infdis/jiaf176.
PubMed 40298376
Marchese AM, Rousculp M, Macbeth J, Beyhaghi H, Seet BT, Toback S. The Novavax Heterologous Coronavirus Disease 2019 Booster Demonstrates Lower Reactogenicity Than Messenger RNA: A Targeted Review. J Infect Dis. 2024 Aug 16;230(2):e496-e502. doi: 10.1093/infdis/jiad519.
PubMed 37992183
Lyke KE, Atmar RL, Dominguez Islas C, Posavad CM, Deming ME, Branche AR, Johnston C, El Sahly HM, Edupuganti S, Mulligan MJ, Jackson LA, Rupp RE, Rostad CA, Coler RN, Backer M, Kottkamp AC, Babu TM, Dobrzynski D, Martin JM, Brady RC, Frenck RW Jr, Rajakumar K, Kotloff K, Rouphael N, Szydlo D, PaulChoudhury R, Archer JI, Crandon S, Ingersoll B, Eaton A, Brown ER, McElrath MJ, Neuzil KM, Stephens DS, Post DJ, Lin BC, Serebryannyy L, Beigel JH, Montefiori DC, Roberts PC; DMID 21-0012 Study Group. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants. NPJ Vaccines. 2023 Jul 11;8(1):98. doi: 10.1038/s41541-023-00693-z.
PubMed 37433788
Lyke KE, Atmar RL, Islas CD, Posavad CM, Szydlo D, Paul Chourdhury R, Deming ME, Eaton A, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Backer M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Archer JI, Crandon S, Zemanek JA, Brown ER, Neuzil KM, Stephens DS, Post DJ, Nayak SU, Suthar MS, Roberts PC, Beigel JH, Montefiori DC; DMID 21-0012 Study Group. Rapid decline in vaccine-boosted neutralizing antibodies against SARS-CoV-2 Omicron variant. Cell Rep Med. 2022 Jul 19;3(7):100679. doi: 10.1016/j.xcrm.2022.100679. Epub 2022 Jun 20.
PubMed 35798000
Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Backer M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Posavad CM, Archer JI, Crandon S, Nayak SU, Szydlo D, Zemanek JA, Dominguez Islas CP, Brown ER, Suthar MS, McElrath MJ, McDermott AB, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Roberts PC, Beigel JH; DMID 21-0012 Study Group. Homologous and Heterologous Covid-19 Booster Vaccinations. N Engl J Med. 2022 Mar 17;386(11):1046-1057. doi: 10.1056/NEJMoa2116414. Epub 2022 Jan 26.
PubMed 35081293

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
ClinicalTrials.gov ID: NCT04889209
Acronym / sponsor ID: 21-0012
Conditions: COVID-19
Keywords: Heterologous Nonvariant Boost, SARS-COV-2, SARS-COV-2 Vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 867 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 28 May 2021 (actual)
Primary completion: 16 Jun 2023 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 17 May 2021 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 18

Arm	Type	Receives
Cohort 1 Group 10E	Experimental	Biological: mRNA-1273.211Adaptive 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 (boost dose). N = 50
Cohort 1 Group 11E	Experimental	Biological: mRNA-1273.211Adaptive 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 (boost dose). N = 50
Cohort 1 Group 12E	Experimental	Biological: mRNA-1273Adaptive 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
Cohort 1 Group 13E	Experimental	Biological: mRNA-1273Adaptive 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
Cohort 1 Group 14E	Experimental	Biological: mRNA-1273Adaptive 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
Cohort 1 Group 15E	Experimental	Biological: SARS-CoV-2 rS/M1Adaptive 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
Cohort 1 Group 16E	Experimental	Biological: SARS-CoV-2 rS/M1Adaptive 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
Cohort 1 Group 17E	Experimental	Biological: SARS-CoV-2 rS/M1Adaptive 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
Cohort 1 Group 1E	Experimental	Biological: mRNA-1273Adaptive 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 (boost dose). N = 50
Cohort 1 Group 2E	Experimental	Biological: mRNA-1273Adaptive 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 (boost dose). N = 50
Cohort 1 Group 3E	Experimental	Biological: mRNA-1273Adaptive 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 (boost dose). N = 50
Cohort 1 Group 4E	Experimental	Biological: Ad26.COV2.SAdaptive 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 (boost dose). N = 50
Cohort 1 Group 5E	Experimental	Biological: Ad26.COV2.SAdaptive 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 (boost dose). N = 50
Cohort 1 Group 6E	Experimental	Biological: Ad26.COV2.SAdaptive 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 (boost dose). N = 50
Cohort 1 Group 7E	Experimental	Biological: BNT162b2Adaptive 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 (boost dose). N = 50
Cohort 1 Group 8E	Experimental	Biological: BNT162b2Adaptive 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 (boost dose). N = 50
Cohort 1 Group 9E	Experimental	Biological: BNT162b2Adaptive 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 (boost dose). N = 50
Cohort 2	Experimental	Biological: mRNA-1273, Biological: mRNA-1273.222A prospective design cohort with naïve to COVID-19 vaccine and infection participants of > / = 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval) followed by a delayed vaccination (50 mcg mRNA-1273) after a minimum of 12 weeks. A second booster (fourth dose) will be administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at a 4-12 month interval N=250

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Participants must meet all of the following criteria to be eligible to participate in this study:
Individuals >/= 18 years of age at the time of consent.
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).
Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health.*

Key exclusion criteria (13 listed)

Known history of SARS-CoV-2 infection. (for Cohort 1 and the primary series of Cohort 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.
Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2 only).
A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles.
Receipt of any investigational study product within 28 days prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ad26.COV2.SFormulated 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.	Biological	Cohort 1 Group 4E, Cohort 1 Group 5E, Cohort 1 Group 6E
BNT162b2A 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).	Biological	Cohort 1 Group 7E, Cohort 1 Group 8E, Cohort 1 Group 9E
mRNA-1273Lipid 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.	Biological	Cohort 1 Group 12E, Cohort 1 Group 13E, Cohort 1 Group 14E, Cohort 1 Group 1E, Cohort 1 Group 2E, Cohort 1 Group 3E, Cohort 2
mRNA-1273.211Lipid 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).	Biological	Cohort 1 Group 10E, Cohort 1 Group 11E
mRNA-1273.222Formulated 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.	Biological	Cohort 2
SARS-CoV-2 rS/M1SARS-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)	Biological	Cohort 1 Group 15E, Cohort 1 Group 16E, Cohort 1 Group 17E

Primary outcome

Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Geometric Mean of Pseudovirus Neutralization against D614G
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
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
Geometric Mean of Pseudovirus Neutralization against BA.1
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
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
Geometric Mean of Pseudovirus Neutralization against BA.4/5
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
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
Geometric Mean of Pseudovirus Neutralization against XBB.1
Frequency of Any Unsolicited Adverse Events (AEs)
Time frame: 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
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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 B.1.1.529 for Cohort 1
Time frame: 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
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Percent of Participants Who Seroconverted Against D614G for Cohort 2
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
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
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
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.1
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
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
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.4/5
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
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
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against XBB.1

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)	53	50
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)	51	47
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)	50	47
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)	50	31
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)	49	41
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)	51	46
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)	53	48
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2	51	46
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)	50	45
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)	43	35
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)	50	44
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)	47	39
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)	50	43
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)	46	44
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)	0	0
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)	16	10
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)	31	22
Cohort 2	106	56

Primary outcome: Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366. Geometric mean (95% Confidence Interval). Unit: Arbitrary Unit*1/dilution

Measure	Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) n = 53	Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) n = 51	Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) n = 50	Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) n = 50	Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) n = 49	Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) n = 51	Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) n = 52	Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) n = 51	Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) n = 50	Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) n = 42	Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) n = 50	Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) n = 50	Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) n = 19	Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) n = 15	Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) n = 29
Day 1, Pre-Dose	2940.97 (2349.82 to 3680.83)	26101.97 (22876.53 to 29782.18)	14223.28 (11259.42 to 17967.32)	2926.70 (2128.92 to 4023.44)	20715.09 (17568.48 to 24425.28)	11549.69 (9316.31 to 14318.48)	3790.32 (2857.23 to 5028.13)	23437.84 (20581.58 to 26690.49)	11448.89 (9385.87 to 13965.38)	4198.32 (2966.41 to 5941.81)	12104.83 (9827.34 to 14910.12)	2314.29 (1712.29 to 3127.94)	13480.35 (10994.14 to 16528.79)	8895.46 (7293.62 to 10849.10)	4423.99 (2495.03 to 7844.25)	17749.73 (10968.10 to 28724.48)	13682.64 (8804.30 to 21263.99)

Population analysed: 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.

Primary outcome: Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366. Geometric mean (95% Confidence Interval). Unit: Arbitrary Unit*1/dilution

Measure	Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) n = 53	Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) n = 51	Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) n = 50	Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) n = 50	Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) n = 49	Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) n = 51	Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) n = 52	Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) n = 51	Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) n = 50	Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) n = 42	Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) n = 50	Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) n = 50	Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) n = 19	Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) n = 15	Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) n = 29
Day 1, Pre-Dose	942.30 (744.40 to 1192.81)	11013.62 (9254.21 to 13107.54)	6047.85 (4839.00 to 7558.69)	954.30 (685.96 to 1327.62)	8076.74 (6708.27 to 9724.36)	5201.78 (4221.65 to 6409.48)	1402.70 (1044.97 to 1882.89)	10079.24 (8831.54 to 11503.21)	5572.24 (4706.89 to 6596.69)	1157.98 (829.29 to 1616.95)

Primary outcome: Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366. Geometric mean (95% Confidence Interval). Unit: Arbitrary Unit*1/dilution

Measure	Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) n = 53	Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) n = 51	Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) n = 50	Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) n = 50	Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) n = 49	Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) n = 51	Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) n = 52	Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) n = 51	Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) n = 50	Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) n = 42	Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) n = 50	Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) n = 50	Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) n = 19	Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) n = 15	Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) n = 29
Day 1, Pre-Dose	1396.82 (1093.87 to 1783.67)	14461.60 (12217.34 to 17118.11)	7615.66 (6046.08 to 9592.70)	1422.80 (1017.63 to 1989.31)	10772.57 (8973.74 to 12931.97)	6473.05 (5240.33 to 7995.76)	1894.19 (1415.79 to 2534.24)	12682.79 (11027.18 to 14586.97)	6603.35 (5520.89 to 7898.04)	1730.28 (1227.75 to 2438.52)

Primary outcome: Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366. Geometric mean (95% Confidence Interval). Unit: Arbitrary Unit*1/dilution

Measure	Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273) n = 53	Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273) n = 51	Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273) n = 50	Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S) n = 50	Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S) n = 49	Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S) n = 51	Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2) n = 52	Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2) n = 51	Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2) n = 50	Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211) n = 42	Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211) n = 50	Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273) n = 50	Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273) n = 46	Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373) n = 19	Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373) n = 15	Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373) n = 29
Day 1, Pre-Dose	355.20 (274.70 to 459.29)	6123.52 (4971.22 to 7542.92)	2749.80 (2052.91 to 3683.26)	350.87 (246.10 to 500.26)	3749.08 (3022.42 to 4650.45)	2052.63 (1587.68 to 2653.76)	502.26 (368.31 to 684.92)	4295.75 (3567.51 to 5172.65)	1860.42 (1479.73 to 2339.06)	484.90 (332.63 to 706.87)	2128.28 (1648.90 to 2747.05)

Adverse events

Time frame: Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)	2 of 53 (3.8%)	49 of 53 (92.5%)	0 of 53
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)	4 of 51 (7.8%)	49 of 51 (96.1%)	1 of 51
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)	0 of 50 (0%)	50 of 50 (100%)	0 of 50
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)	1 of 50 (2%)	46 of 50 (92%)	0 of 50
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)	1 of 49 (2%)	46 of 49 (93.9%)	0 of 49
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)	2 of 51 (3.9%)	47 of 51 (92.2%)	0 of 51
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)	1 of 52 (1.9%)	52 of 52 (100%)	0 of 52
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)	1 of 51 (2%)	50 of 51 (98%)	0 of 51
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)	0 of 50 (0%)	50 of 50 (100%)	0 of 50
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)	0 of 43 (0%)	43 of 43 (100%)	0 of 43
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)	2 of 50 (4%)	48 of 50 (96%)	0 of 50
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)	1 of 47 (2.1%)	46 of 47 (97.9%)	0 of 47
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)	1 of 50 (2%)	49 of 50 (98%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40298376Atmar RL, Lyke KE, Posavad CM, Deming ME, Brady RC, Dobrzynski D, Edupuganti S, Mulligan MJ, Rupp RE, Rostad CA, Jackson LA, Martin JM, Shriver MC, Rajakumar K, Coler RN, El Sahly HM, Kottkamp AC, Branche AR, Frenck RW, Johnston C, Babu TM, Backer M, Archer JI, Crandon S, Nakamura A, Nayak SU, Szydlo D, Dominguez Islas CP, Brown ER, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Beigel JH, Pasetti M, Roberts PC. Mucosal and Systemic Antibody Responses After Boosting With a Bivalent Messenger RNA Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine. J Infect Dis. 2025 Oct 15;232(4):971-981. doi: 10.1093/infdis/jiaf176.
Derived from this study: PubMed 37992183Marchese AM, Rousculp M, Macbeth J, Beyhaghi H, Seet BT, Toback S. The Novavax Heterologous Coronavirus Disease 2019 Booster Demonstrates Lower Reactogenicity Than Messenger RNA: A Targeted Review. J Infect Dis. 2024 Aug 16;230(2):e496-e502. doi: 10.1093/infdis/jiad519.
Derived from this study: PubMed 37433788Lyke KE, Atmar RL, Dominguez Islas C, Posavad CM, Deming ME, Branche AR, Johnston C, El Sahly HM, Edupuganti S, Mulligan MJ, Jackson LA, Rupp RE, Rostad CA, Coler RN, Backer M, Kottkamp AC, Babu TM, Dobrzynski D, Martin JM, Brady RC, Frenck RW Jr, Rajakumar K, Kotloff K, Rouphael N, Szydlo D, PaulChoudhury R, Archer JI, Crandon S, Ingersoll B, Eaton A, Brown ER, McElrath MJ, Neuzil KM, Stephens DS, Post DJ, Lin BC, Serebryannyy L, Beigel JH, Montefiori DC, Roberts PC; DMID 21-0012 Study Group. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants. NPJ Vaccines. 2023 Jul 11;8(1):98. doi: 10.1038/s41541-023-00693-z.
Derived from this study: PubMed 35798000Lyke KE, Atmar RL, Islas CD, Posavad CM, Szydlo D, Paul Chourdhury R, Deming ME, Eaton A, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Backer M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Archer JI, Crandon S, Zemanek JA, Brown ER, Neuzil KM, Stephens DS, Post DJ, Nayak SU, Suthar MS, Roberts PC, Beigel JH, Montefiori DC; DMID 21-0012 Study Group. Rapid decline in vaccine-boosted neutralizing antibodies against SARS-CoV-2 Omicron variant. Cell Rep Med. 2022 Jul 19;3(7):100679. doi: 10.1016/j.xcrm.2022.100679. Epub 2022 Jun 20.
Derived from this study: PubMed 35081293Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Backer M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Posavad CM, Archer JI, Crandon S, Nayak SU, Szydlo D, Zemanek JA, Dominguez Islas CP, Brown ER, Suthar MS, McElrath MJ, McDermott AB, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Roberts PC, Beigel JH; DMID 21-0012 Study Group. Homologous and Heterologous Covid-19 Booster Vaccinations. N Engl J Med. 2022 Mar 17;386(11):1046-1057. doi: 10.1056/NEJMoa2116414. Epub 2022 Jan 26.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kirsten E Lyke, M.D. study chair

University of Maryland School of Medicine, Center for Vaccine Development and Global Health

Robert L Atmar, M.D. study chair

Baylor College of Medicine

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ad26.COV2.S, BNT162b2 and mRNA-1273 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1 (time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04889209, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.