Phase:Open Label
Principal Investigator(s):David Diemert, Julie McElrath
Objective:A Phase I study that began in 2018 to test an innovative engineered HIV vaccine candidate. • The trial was designed to assess the safety of the vaccine candidate and to test the hypothesis that an immunogen could activate naïve B cells of the immune system that produce precursors to a certain type of broadly neutralizing antibody (bnAb). This type of bnAb, known as a VRC01- class antibody, targets an area on the HIV surface protein Env known as the CD4 binding site. The strategy of targeting naïve B cells with specific properties is called “germline targeting,” as these B cells display antibodies encoded by unmutated, or “germline,” genes.Key Results No safety concerns arose among participants. 97% of participants who were vaccinated developed detectable VRC01-class immunoglobulin G (IgG) B cells. The frequency of these responses — meaning how frequently these VRC01-class B cells were detected among all IgG B cells — was high enough to be considered promising for boosting as a next step. Last updated June 10, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Official Code: NCT03547245
Trial Sponsors: Bill & Melinda Gates Foundation, CHAVD, NIAID
Start Date
End Date
June 1, 2018
August 13, 2021
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women