Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

March 31, 2021

Primary Completion Date

July 5, 2022

Study Completion Date

July 5, 2022

Conditions
COVID-19COVID-19 Immunisation
Interventions
BIOLOGICAL

mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.

BIOLOGICAL

mRNA-1273.351

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.

Trial Locations (4)

30030-1705

The Hope Clinic of Emory University, Decatur

45229-3039

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

37232-0004

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center, Nashville

98101-1466

Kaiser Permanente Washington Health Research Institute, Seattle

All Listed Sponsors
collaborator

ModernaTX, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04785144 - Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults | Biotech Hunter | Biotech Hunter