CompletedPhase 2

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

United States1,270 participantsStarted 2022-03-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s).

What they're measuring

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

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

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

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

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

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

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

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

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

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

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

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

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

Trial details

NCT IDNCT05289037

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-11-22

Results submitted2024-11-14

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s).

What they're measuring

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

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

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

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

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

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

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

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

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

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

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

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

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