COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Adaptive, COVAIL, Covid-19, Multivalent, Omicron, SARS-CoV-2, Vaccine, Variants
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Sites / Locations
- University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic
- University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)
- Zuckerberg San Francisco General Hospital, UCSF Positive Health Program
- George Washington University Medical Faculty Associates
- Howard University - Department of Medicine - Division of Infectious Disease
- Morehouse School of Medicine - Clinical Research Center
- Emory University School of Medicine
- The Hope Clinic of Emory University
- University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
- University of Iowa Hospitals & Clinics - Department of Internal Medicine
- Tulane University Clinical Translational Unit
- Brigham and Women's Hospital
- Saint Louis University Center for Vaccine Development
- Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
- NYU Grossman Long Island School of Medicine - Vaccine Center
- NYU Langone Vaccine Center Research Clinic, Manhattan
- University of Rochester Medical Center - Vaccine Research Unit
- Duke Vaccine and Trials Unit
- Baylor College of Medicine
- University of Texas Medical Branch
- Kaiser Permanente Washington Health Research Institute
- The University of Washington - Virology Research Clinic
Arms of the Study
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mRNA-1273 administered through 0.2 mg/ml intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
0.2 mg/ml of mRNA-1273.617.2 and 0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
0.2 mg/ml of mRNA-1273.529 and mRNA-1273 0.2 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL of BNT162b2 (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL of BNT162b2 (Omicron) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL CoV2 preS dTM-AS03 [D614] (prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL CoV2 preS dTM-AS03 [B.1.351] (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
500 mcg/mL CoV2 preS dTM-AS03 [D614 + B.1.351] (prototype + Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.1) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100