COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
Public ClinicalTrials.gov record NCT05289037. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05289037
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,270 participants
Conditions and interventions
Conditions
Interventions
- AS03 Drug
- BNT162b2 Biological
- BNT162b2 (B.1.1.529) Biological
- BNT162b2 (B.1.351) Biological
- BNT162b2 bivalent (wildtype and Omicron BA.1) Biological
- BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5) Biological
- CoV2 preS dTM [B.1.351] Biological
- CoV2 preS dTM/D614 Biological
- CoV2 preS dTM/D614+B.1.351 Biological
- mRNA-1273 Biological
- mRNA-1273.351 Biological
- mRNA-1273.529 Biological
- mRNA-1273.617.2 Biological
- Sodium Chloride, 0.9% Other
Drug · Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2022
- Primary completion
- Nov 21, 2023
- Completion
- Nov 26, 2023
- Last update posted
- Oct 19, 2025
2022 – 2023
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic | Birmingham | Alabama | 35294 | — |
| 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 | — |
| 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 | — |
| Morehouse School of Medicine - Clinical Research Center | Atlanta | Georgia | 30310 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1013 | — |
| The Hope Clinic of Emory University | Decatur | Georgia | 30030-1705 | — |
| University of Illinois at Chicago College of Medicine - Division of Infectious Diseases | Chicago | Illinois | 60612 | — |
| University of Iowa Hospitals & Clinics - Department of Internal Medicine | Iowa City | Iowa | 52242 | — |
| Tulane University Clinical Translational Unit | New Orleans | Louisiana | 70112 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115-6110 | — |
| 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 | — |
| NYU Grossman School, NYU Langone Vaccine Center, Long Island | Mineola | New York | 11501 | — |
| 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 | — |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | — |
| Baylor College of Medicine | Houston | Texas | 77030-3411 | — |
| University of Texas Medical Branch | League City | Texas | 77573 | — |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | — |
| The University of Washington - Virology Research Clinic | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05289037, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05289037 live on ClinicalTrials.gov.