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NCT05289037 · ClinicalTrials.gov registry record · Phase 2
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 1,270
- Enrollment target
NCT05289037: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05289037 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,270 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (855% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05289037, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,270 participants
- Enrollment target
Study 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, 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL BNT162b2
- DRUG AS03
- BIOLOGICAL BNT162b2 (B.1.1.529)
- BIOLOGICAL BNT162b2 (B.1.351)
- BIOLOGICAL BNT162b2 bivalent (wildtype and Omicron BA.1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,270 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 2 |
What the finished NCT05289037 record still lists
NCT05289037 is an interventional study that assigns participants to a tested intervention. Its 1,270 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (855% higher).
The record links to 0 conditions, and to 5 interventions - of which BNT162b2 is the first listed.
NCT05289037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05289037 about?
NCT05289037 is a clinical study titled "COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)". 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 wil...
What is the current status of trial NCT05289037?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,270 participants. The study started on 2022-03-30. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT05289037?
The interventions under investigation include: BNT162b2 (BIOLOGICAL), AS03 (DRUG), BNT162b2 (B.1.1.529) (BIOLOGICAL), BNT162b2 (B.1.351) (BIOLOGICAL), BNT162b2 bivalent (wildtype and Omicron BA.1) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05289037?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05289037's enrollment target sits among peer trials
1,270 15th of 2000 higher than 1,986 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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