COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

PHASE2CompletedINTERVENTIONAL
Enrollment

1,270

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

November 22, 2023

Study Completion Date

November 27, 2023

Conditions
COVID-19
Interventions
DRUG

AS03

AS03 oil-in-water emulsion adjuvant.

BIOLOGICAL

BNT162b2

A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.

BIOLOGICAL

BNT162b2 (B.1.1.529)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

BIOLOGICAL

BNT162b2 (B.1.351)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.

BIOLOGICAL

BNT162b2 bivalent (wildtype and Omicron BA.1)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.1 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

BIOLOGICAL

BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

BIOLOGICAL

CoV2 preS dTM [B.1.351]

Is a liquid formulation made of recombinant protein placed in a formulation buffer that contains the spike protein sequence of the B.1.351 (Beta) variant SARS-CoV-2 strain.

BIOLOGICAL

CoV2 preS dTM/D614

Is a liquid formulation made of recombinant protein placed in a formulation buffer. The antigen solution contains the spike protein sequence of the ancestral strain of SARS-CoV-2.

BIOLOGICAL

CoV2 preS dTM/D614+B.1.351

Is a liquid formulation made of recombinant protein placed in a formulation buffer contains the spike protein sequences of the ancestral and B.1.351 (Beta) variant SARS-CoV-2 strains

BIOLOGICAL

mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).

BIOLOGICAL

mRNA-1273.351

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351 variant SARS-CoV-2 strain.

BIOLOGICAL

mRNA-1273.529

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

BIOLOGICAL

mRNA-1273.617.2

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.617.2 (Delta) variant SARS-CoV-2 strain.

OTHER

Sodium Chloride, 0.9%

0.9% Sodium Chloride Injection

Trial Locations (22)

10016

NYU Langone Vaccine Center Research Clinic, Manhattan, New York

11501

NYU Grossman School, NYU Langone Vaccine Center, Long Island, Mineola

20060

Howard University - Department of Medicine - Division of Infectious Disease, Washington D.C.

27703

Duke Vaccine and Trials Unit, Durham

30310

Morehouse School of Medicine - Clinical Research Center, Atlanta

35294

University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic, Birmingham

52242

University of Iowa Hospitals & Clinics - Department of Internal Medicine, Iowa City

60612

University of Illinois at Chicago College of Medicine - Division of Infectious Diseases, Chicago

63110

Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit, St Louis

70112

Tulane University Clinical Translational Unit, New Orleans

77573

University of Texas Medical Branch, League City

94110

Zuckerberg San Francisco General Hospital, UCSF Positive Health Program, San Francisco

98101

Kaiser Permanente Washington Health Research Institute, Seattle

98104

The University of Washington - Virology Research Clinic, Seattle

92103-8208

University of California, San Diego (UCSD) - Antiviral Research Center (AVRC), San Diego

20037-3201

George Washington University Medical Faculty Associates, Washington D.C.

30322-1013

Emory University School of Medicine, Atlanta

30030-1705

The Hope Clinic of Emory University, Decatur

02115-6110

Brigham and Women's Hospital, Boston

63104-1015

Saint Louis University Center for Vaccine Development, St Louis

14611-3201

University of Rochester Medical Center - Vaccine Research Unit, Rochester

77030-3411

Baylor College of Medicine, Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH