COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

Completed · Phase 2

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05289037

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1270

Starts

2022-03-30

Expected to finish

2023-11-27

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic — Birmingham, Alabama, United States
• University of California, San Diego (UCSD) - Antiviral Research Center (AVRC) — San Diego, California, United States
• Zuckerberg San Francisco General Hospital, UCSF Positive Health Program — San Francisco, California, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Howard University - Department of Medicine - Division of Infectious Disease — Washington D.C., District of Columbia, United States
• Morehouse School of Medicine - Clinical Research Center — Atlanta, Georgia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• The Hope Clinic of Emory University — Decatur, Georgia, United States
• University of Illinois at Chicago College of Medicine - Division of Infectious Diseases — Chicago, Illinois, United States
• University of Iowa Hospitals & Clinics - Department of Internal Medicine — Iowa City, Iowa, United States
• Tulane University Clinical Translational Unit — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Saint Louis University Center for Vaccine Development — St Louis, Missouri, United States
• Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit — St Louis, Missouri, United States
• NYU Grossman School, NYU Langone Vaccine Center, Long Island — Mineola, New York, United States
• NYU Langone Vaccine Center Research Clinic, Manhattan — New York, New York, United States
• University of Rochester Medical Center - Vaccine Research Unit — Rochester, New York, United States
• Duke Vaccine and Trials Unit — Durham, North Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Medical Branch — League City, Texas, United States
• Kaiser Permanente Washington Health Research Institute — Seattle, Washington, United States
• The University of Washington - Virology Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.