March 17, 2022

HVTN 302 begins first dosing of mRNA HIV vaccine antigens

HVTN, NIAID, and Moderna partner on trial of HIV Env trimers designed by IAVI's William Schief.

William SchiefWilliam Schief, Ph.D.

IAVI congratulates our colleagues at the HIV Vaccine Trials Network (HVTN), the National Institute of Allergy and Infectious Diseases (NIAID), and Moderna on the start of the Phase I clinical trial HVTN 302 (NCT05217641). The partners issued press releases on March 14, 2022, to mark first dosing of trial volunteers.

The trial is evaluating safety and immune responses to receipt of stabilized HIV Env trimers delivered via mRNA. The trimers were developed under the leadership of IAVI Neutralizing Antibody Center executive director of vaccine design and Scripps Research Professor William Schief, Ph.D. The trial is sponsored by the Division of AIDS (DAIDS) of NIAID within the National Institutes of Health (NIH). The vaccine material is provided by IAVI with support from the Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD).

While these investigational vaccine antigens on their own will not lead to a licensed, efficacious HIV vaccine, they could eventually be part of a sequence of antigens that could lead to the production in the recipient of broadly neutralizing antibodies that could prevent acquisition of HIV. IAVI is sponsoring a trial, IAVI G002, of other mRNA-encoded vaccine antigens developed by Dr. Schief that could be part of such a sequential vaccination approach.

See the press releases below for more information about the study design and research questions underlying HVTN 302.

HVTN: Trial of innovative HIV vaccine using mRNA technology enrolls first participant

NIAID: NIH launches clinical trial of three mRNA HIV vaccines

Moderna: Moderna announces first participant dosed in phase I study of its HIV trimer mRNA vaccine