Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

867

Participants

Timeline

Start Date

May 28, 2021

Primary Completion Date

June 16, 2023

Study Completion Date

June 16, 2023

Conditions
COVID-19
Interventions
BIOLOGICAL

Ad26.COV2.S

Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-ß-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.

BIOLOGICAL

BNT162b2

A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).

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). Doses are either 0.25 mL or 0.5 mL.

BIOLOGICAL

mRNA-1273.211

Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).

BIOLOGICAL

mRNA-1273.222

Formulated in the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.

BIOLOGICAL

SARS-CoV-2 rS/M1

SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)

Trial Locations (10)

10016

NYU Langone Vaccine Center, New York

14642

University of Rochester Medical Center - Vaccine Research Unit, Rochester

98104

The University of Washington - Virology Research Clinic, Seattle

30030-1705

The Hope Clinic of Emory University, Decatur

21201-1009

University of Maryland Baltimore - Institute of Human Virology, Baltimore

45206-1613

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati

15213-3205

University of Pittsburgh - Medicine - Infectious Diseases, Pittsburgh

77555-0435

University of Texas Medical Branch, Galveston

77030-3411

Baylor College of Medicine, Houston

98101-1466

Kaiser Permanente Washington Health Research Institute, Seattle

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH