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IAVI G002

Status
Ongoing
Phase
I
Principal Investigator(s)
Dagna Laufer
Objective


A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

Last edited June 10, 2022

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Biological: eOD-GT8 60mer mRNA Vaccine 100µg, Intramuscularly
Mode of Delivery
Intramuscular
Products
mRNA-1644 (eOD-GT8 60mer)
ARMs
Experimental
Description
Biological: Core-g28v2 60mer mRNA Vaccine 100µg, Intramuscularly Biological: eOD-GT8 60mer mRNA Vaccine 100µg, Intramuscularly
Mode of Delivery
Intramuscular
Products
mRNA-1644 (eOD-GT8 60mer)
ARMs
Experimental
Description
Biological: Core-g28v2 60mer mRNA Vaccine 100µg, Intramuscularly Biological: eOD-GT8 60mer mRNA Vaccine 100µg, Intramuscularly
Mode of Delivery
Intramuscular
Products
mRNA-1644 (eOD-GT8 60mer)
ARMs
Experimental
Description
Biological: Core-g28v2 60mer mRNA Vaccine 100µg, Intramuscularly
Mode of Delivery
Intramuscular
Products
mRNA-1644 (eOD-GT8 60mer)
Trial Sponsors
International AIDS Vaccine Initiative; ModernaTX, Inc.; The University of Texas at San Antonio; George Washington University; Fred Hutchinson Cancer Research Center; Emory University
Product Developers
International AIDS Vaccine Initiative
November 2021
April 2023
Enrollment
56
18
Years
50
Years
Population
Men
Women
Sites

Fred Hutchinson Cancer Research Center

Seattle
United States of America

University of Texas Medical Branch

Galveston, Texas
United States of America

Emory Hospital Midtown Infectious Disease Clinic

Atlanta
United States of America

George Washington University CRS

Washington, District of Columbia
United States of America