A Phase 1 Study (IAVI G003) to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.
The hypothesis is that the eOD-GT8 60mer mRNA Vaccine (mRNA-1644) as a "germline-targeting" immunogen will generate detectable VRC01-class IgG B-cells in African populations.
There is no blinding and no randomization in this open-label study. Participants will be screened up to 56 days before the first IP administration and will be actively followed for 6 months after the last IP administration.
The total study duration, including screening and enrollment, is approximately 13 months. Participants are expected to be in the study for 10 months, from screening to the last study visit. The study is expected to screen and enroll over 3 months.