AzTrials
AzTrials

COVID-19Phase 2NCT05289037

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

A Phase 2 study testing AS03, BNT162b2 and BNT162b2 (B.1.1.529) in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 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

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
AS03, BNT162b2 and BNT162b2 (B.1.1.529)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,270 participants
Where
22 sitesUnited States
Study dates
30 Mar 2022to 27 Nov 2023
Phase
Phase 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 years and older
  • 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. (18-49 years for stage 4).
  • Confirmed receipt of a complete primary and booster COVID-19 vaccine series, either homologous or heterologous, with an FDA authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1.
  • 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 stable state of health.
  • Note: Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.

Who cannot join

  • Participants meeting any of the following criteria will be excluded from the study:
  • Confirmed SARS-CoV-2 infection < 16 weeks prior to any study vaccine dose.
  • Pregnant and breastfeeding participants.
  • Prior administration of an investigational coronavirus vaccine at any time or SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy in the preceding 3 months.
  • Note: subjects that participated in clinical trials of products that are now FDA approved/authorized are allowed to participate.
  • Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s).
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  • A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine, polyethylene glycol (PEG), polysorbate or nanolipid particles.
  • A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1, 2 and 4).
  • Received or plans to receive a vaccine within 28 days prior to or after any dose of study vaccine.
  • Note: Receipt of seasonal influenza vaccine is allowed at any time.
  • Bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or bleeding difficulties with intramuscular injections or blood draws.
  • Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition.
  • Advanced liver or kidney diseases.
  • Advanced (CD4 count < 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C.
  • Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids = 20 mg > / = day of prednisone equivalent).
  • Note: Topical medications are allowed.
  • Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose.
  • Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose.
  • Study personnel or an immediate family member or household member of study personnel.
  • Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as > / = 38.0 degrees Celsius/100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods.
  • Note: Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator, as long as the illness is not suggestive of COVID-19.
  • Plan to receive a COVID-19 booster vaccine outside of the study within the next 180 days. (for subjects in Stage 4 only)

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Morehouse School of Medicine - Clinical Research Center

    Atlanta, Georgia, 30310

  • Emory University School of Medicine

    Atlanta, Georgia, 30322-1013

  • University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115-6110

  • University of Illinois at Chicago College of Medicine - Division of Infectious Diseases

    Chicago, Illinois, 60612

  • The Hope Clinic of Emory University

    Decatur, Georgia, 30030-1705

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

  • Baylor College of Medicine

    Houston, Texas, 77030-3411

  • University of Iowa Hospitals & Clinics - Department of Internal Medicine

    Iowa City, Iowa, 52242

  • University of Texas Medical Branch

    League City, Texas, 77573

  • NYU Grossman School, NYU Langone Vaccine Center, Long Island

    Mineola, New York, 11501

  • Tulane University Clinical Translational Unit

    New Orleans, Louisiana, 70112

  • NYU Langone Vaccine Center Research Clinic, Manhattan

    New York, New York, 10016

  • University of Rochester Medical Center - Vaccine Research Unit

    Rochester, New York, 14611-3201

  • University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)

    San Diego, California, 92103-8208

  • Zuckerberg San Francisco General Hospital, UCSF Positive Health Program

    San Francisco, California, 94110

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101

  • The University of Washington - Virology Research Clinic

    Seattle, Washington, 98104

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104-1015

  • Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit

    St Louis, Missouri, 63110

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037-3201

  • Howard University - Department of Medicine - Division of Infectious Disease

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) >/ = 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination.

Read the detailed description

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) >/= 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. This is an adaptive design and may add arms of new vaccine platforms and/or variant lineage spike vaccines as needed. The study arms will be conducted in different stages (that could overlap) depending on public health needs and the availability of study products (starting with the available mRNA vaccines). The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination. The secondary objective is to evaluate the safety of candidate SARS-CoV-2 variant vaccines, as assessed by: a) Local and systemic solicited Adverse Events for 7 days following each vaccine dose; b) Unsolicited Adverse Events from Dose 1 to 28 days following each vaccine dose; c) Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interests (AESIs), New Onset of Chronic Medical (NOCMCs) and Adverse Events (AEs) leading to withdrawal from the study from Dose 1 to 12 months after last vaccine dose.

Conditions
COVID-19
Being tested
AS03, BNT162b2, BNT162b2 (B.1.1.529), BNT162b2 (B.1.351), BNT162b2 bivalent (wildtype and Omicron BA.1)
Keywords
Adaptive, COVAIL, Covid-19, Multivalent, Omicron, SARS-CoV-2, Vaccine, Variants
Medical subject headings
COVID-19

What participants receive

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

  • AS03Drug

    AS03 oil-in-water emulsion adjuvant.

  • BNT162b2Biological

    A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.

  • BNT162b2 (B.1.1.529)Biological

    A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

  • BNT162b2 (B.1.351)Biological

    A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.

  • BNT162b2 bivalent (wildtype and Omicron BA.1)Biological

    A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.1 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

  • BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)Biological

    A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

  • CoV2 preS dTM [B.1.351]Biological

    Is a liquid formulation made of recombinant protein placed in a formulation buffer that contains the spike protein sequence of the B.1.351 (Beta) variant SARS-CoV-2 strain.

  • CoV2 preS dTM/D614Biological

    Is a liquid formulation made of recombinant protein placed in a formulation buffer. The antigen solution contains the spike protein sequence of the ancestral strain of SARS-CoV-2.

  • CoV2 preS dTM/D614+B.1.351Biological

    Is a liquid formulation made of recombinant protein placed in a formulation buffer contains the spike protein sequences of the ancestral and B.1.351 (Beta) variant SARS-CoV-2 strains

  • 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).

  • mRNA-1273.351Biological

    Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351 variant SARS-CoV-2 strain.

  • mRNA-1273.529Biological

    Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

  • mRNA-1273.617.2Biological

    Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.617.2 (Delta) variant SARS-CoV-2 strain.

  • Sodium Chloride, 0.9%Other

    0.9% Sodium Chloride Injection

Study groups in NCT05289037
Study groupRoleWhat they receive
Arm 01ExperimentalmRNA-1273 administered through 0.2 mg/ml intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273; Other: Sodium Chloride, 0.9%
Arm 02Experimental0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273.351; Biological: mRNA-1273.529; Other: Sodium Chloride, 0.9%
Arm 03Experimental0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273.351; Biological: mRNA-1273.529; Other: Sodium Chloride, 0.9%
Arm 04Experimental0.2 mg/ml of mRNA-1273.617.2 and 0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273.529; Biological: mRNA-1273.617.2; Other: Sodium Chloride, 0.9%
Arm 05Experimental0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273.529; Other: Sodium Chloride, 0.9%
Arm 06Experimental0.2 mg/ml of mRNA-1273.529 and mRNA-1273 0.2 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
Receives: Biological: mRNA-1273; Biological: mRNA-1273.529; Other: Sodium Chloride, 0.9%
Arm 07Experimental500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2
Arm 08Experimental500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2 (B.1.1.529); Biological: BNT162b2 (B.1.351)
Arm 09Experimental500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2 (B.1.1.529)
Arm 10Experimental500 mcg/mL of BNT162b2 (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2 (B.1.351)
Arm 11Experimental500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2; Biological: BNT162b2 (B.1.351)
Arm 12Experimental500 mcg/mL of BNT162b2 (Omicron) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Biological: BNT162b2; Biological: BNT162b2 (B.1.1.529)
Arm 13Experimental500 mcg/mL CoV2 preS dTM-AS03 [D614] (prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Drug: AS03; Biological: CoV2 preS dTM/D614
Arm 14Experimental500 mcg/mL CoV2 preS dTM-AS03 [B.1.351] (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Drug: AS03; Biological: CoV2 preS dTM [B.1.351]
Arm 15Experimental500 mcg/mL CoV2 preS dTM-AS03 [D614 + B.1.351] (prototype + Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
Receives: Drug: AS03; Biological: CoV2 preS dTM/D614+B.1.351
Arm 16Experimental100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.1) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100
Receives: Biological: BNT162b2 bivalent (wildtype and Omicron BA.1)
Arm 17Experimental100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100
Receives: Biological: BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)

What is being measured

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

  1. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 91, Day 181, Day 271, Day 366

  2. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  3. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 91, Day 181, Day 271, Day 366

  4. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  5. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 91, Day 181, Day 271, Day 366

  6. Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.

    Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  7. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  8. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.

    Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  9. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  10. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.

    Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

    Measured: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  11. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

    Measured: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  12. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.

    Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

    Measured: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  13. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value The geometric mean of the fold rise is then reported

    Measured: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  14. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.

    Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  15. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against BA.2.12.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15

  16. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.

    Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  17. Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.

    Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

    Measured: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  18. Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.

    Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

  19. Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.

    Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  20. Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.

    Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

  21. Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.

    Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  22. Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.

    Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

  23. Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.

    Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units*1/dilution.

    Measured: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  24. Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  25. Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.

    Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  26. Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  27. Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.

    Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  28. Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  29. Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.

    Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  30. Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  31. Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.

    Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  32. Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1.

    Measured: Day 1 Pre-Booster Dose, Day 15

  33. Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.

    Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  34. Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.

    Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  35. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.

    GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  36. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.

    GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  37. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.

    GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  38. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.

    GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  39. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.

    GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  40. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.

    GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

  41. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.

    GMR to D614G variant of Pseudovirus Neutralization Against BA.2.12.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15

  42. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.

    GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

  43. Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.

    GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

    Measured: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Secondary outcomes (8)

  1. Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.

    Number of participants that experienced any AE during the course of the study that resulted in withdrawal from the study.

    Measured: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

  2. Frequency of Any Adverse Events of Special Interest (AESIs)

    Number of participants that experienced any AESI during the course of the study.

    Measured: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

  3. Frequency of Any Medically Attended Adverse Events (MAAEs)

    Number of participants that experienced any MAAE during the course of the study. Medically Attended Adverse Events (MAAEs) are defined as a hospitalization < 24 hours, emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason; and considered related or possibly related to study product

    Measured: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

  4. Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)

    Number of participants that experienced any NOCMC during the course of the study.

    Measured: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

  5. Frequency of Any Serious Adverse Events (SAEs)

    Number of participants that experienced any SAEs during the course of the study. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

    Measured: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

  6. 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 Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.

  7. 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: Injection Site Pain, Injection site Erythema, and Injection site Edema/Induration.

    Measured: Day 1 through Day 8 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.

  8. Frequency of Any Unsolicited Adverse Events (AEs)

    Number of participants that experienced any Unsolicited AEs through 28 days post vaccination.

    Measured: Day 1 through Day 29 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and 28 days post any vaccination for Arm 3.

Timeline

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

  1. First posted21 Mar 2022
  2. Study start30 Mar 2022
  3. Primary completion22 Nov 2023
  4. Study completion27 Nov 2023

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289037
Sponsor's protocol ID
22-0004
Other IDs
5UM1AI148684-03
Status last verified
3 Oct 2022
First submitted
17 Mar 2022
Last updated
20 Oct 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Heng F, Magaret CA, Rouphael NG, Branche AR, Fong Y, Carpp LN, Yu C, Chen S, Zhang B, Diemert DJ, Falsey AR, Graciaa DS, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Backer M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Mu J, Makowski M, Makhene MK, Nayak SU, Simon V, van Bakel H, Roberts PC, Gilbert PB; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. The neutralizing antibody titer correlate of COVID-19 risk in the COVID-19 variant immunologic landscape (COVAIL) trial was not modified by SARS-CoV-2 amino acid sequence distances. Vaccine. 2026 Mar 19;76:128348. doi: 10.1016/j.vaccine.2026.128348. Epub 2026 Feb 15.

    PubMed 41698311

  • Diemert DJ, Graciaa DS, Zhang B, Rouphael NG, Branche AR, Martin TCS, Jackson LA, Presti RM, Kamidani S, Mahgoub SM, Babu TM, Magaret CA, Simon V, van Bakel H, Roberts PC, Beigel JH, Gilbert PB, Follmann D; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Effect of Omicron BA.1-based compared to prototype booster mRNA vaccination on incidence of COVID-19 in the COVAIL trial. Vaccine. 2025 Oct 3;64:127718. doi: 10.1016/j.vaccine.2025.127718. Epub 2025 Sep 9.

    PubMed 40930044

  • Fong Y, Dang L, Zhang B, Fintzi J, Chen S, Wang J, Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Yu C, Magaret CA, Molitor C, Borate B, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Backer M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Mu J, Makowski M, Makhene MK, Nayak SU, Roberts PC, Follmann D, Gilbert PB; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial. Clin Infect Dis. 2025 Feb 5;80(1):223-227. doi: 10.1093/cid/ciae465.

    PubMed 39325506

  • Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Backer M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Kamidani S, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Tureli S, Makhene M, Crandon S, Montefiori DC, Makowski M, Smith DJ, Nayak SU, Roberts PC, Beigel JH; COVAIL Study Group. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial. Nat Med. 2023 Sep;29(9):2334-2346. doi: 10.1038/s41591-023-02503-4. Epub 2023 Aug 28.

    PubMed 37640860

  • Branche A, Rouphael N, Diemert D, Falsey A, Losada C, Baden LR, Frey S, Whitaker J, Little S, Anderson E, Walter E, Novak R, Rupp R, Jackson L, Babu T, Kottkamp A, Luetkemeyer A, Immergluck L, Presti R, Backer M, Winokur P, Mahgoub S, Goepfert P, Fusco D, Malkin E, Bethony J, Walsh E, Graciaa D, Samaha H, Sherman A, Walsh S, Abate G, Oikonomopoulou Z, El Sahly H, Martin T, Kamidani S, Smith M, Ladner B, Porterfield L, Dunstan M, Wald A, Davis T, Atmar R, Mulligan M, Lyke K, Posavad C, Meagher M, Stephens D, Neuzil K, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis T, Giebeig L, Eaton A, Netzl A, Wilks S, Tureli S, Makhene M, Crandon S, Montefiori D, Makowski M, Smith D, Nayak S, Roberts P, Beigel J. Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2653179. doi: 10.21203/rs.3.rs-2653179/v1.

    PubMed 37205592

  • Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Backer M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Rostad CA, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Tureli S, Makhene M, Crandon S, Lee M, Nayak SU, Montefiori DC, Makowski M, Smith DJ, Roberts PC, Beigel JH; COVAIL Study Group. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses. medRxiv [Preprint]. 2022 Jul 15:2022.07.12.22277336. doi: 10.1101/2022.07.12.22277336.

    PubMed 35898343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AS03, BNT162b2 and BNT162b2 (B.1.1.529) in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 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 6 inclusion and 22 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 phase mean?

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 14 Mar 2025). 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 Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups. (time frame: Day 29, Day 91, Day 181, Day 271, Day 366). The study lists 43 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 NCT05289037, which also lists 6 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 Oct 2025.

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