COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

• Status: Recruiting
• Trial end date: 2026-03-28
• Target enrollment: 0
• Participant gender: All

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) 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) and approximately 20% to have had confirmed COVID-19.The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible to participate in this study:

1. Individuals > / = 18 years of age at the time of consent.

2. Confirmed receipt of a complete primary and booster COVID-19 vaccine series, either homologous or heterologous, with a Federal Drug Administration (FDA) authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1.

3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.

4. 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.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

1. Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection < 16 weeks prior to any study vaccine dose.

2. Pregnant or breastfeeding participants.

3. 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.

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

5. 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.

6. A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1 and 2).

7. 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.

8. 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.

9. Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition.

10. Advanced liver or kidney diseases.

11. Advanced (CD4 count < 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C.

12. 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).

13. Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose.

14. Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose.

15. Study personnel or an immediate family member or household member of study personnel.

16. 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.