Status:
COMPLETED
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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)
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
1270 Patients enrolled
Trial Details
Trial ID
NCT05289037
Start Date
March 30 2022
End Date
November 27 2023
Last Update
October 17 2025
Active Locations (22)
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1
University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic
Birmingham, Alabama, United States, 35294
2
University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)
San Diego, California, United States, 92103-8208
3
Zuckerberg San Francisco General Hospital, UCSF Positive Health Program
San Francisco, California, United States, 94110
4
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037-3201