Principal Investigator(s):Julien Nyombayire; Anthony Sebe
Objective:A Phase 1 Study 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 eOD-GT8 60mer mRNA Vaccine as a "germline-targeting" immunogen will generate detectable VRC01-class IgG B-cells in African populations. Eighteen participants. An over-enrollment of up to 2 participants will be permitted to facilitate rapid enrollment. Participants who leave the study for any reason will not be replaced. Adults ≥18 and ≤50 years of age who meet all protocol inclusion criteria, who do not meet any protocol exclusion criteria, who understand the study (as demonstrated by the Assessment of [Informed Consent] Understanding [AOU]), and who can provide written informed consent. Administration of eOD-GT8 60mer mRNA Vaccine (100µg) will occur on Week 0 and Week 8. 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. A participant is expected to be in the study for 10 months from screening to last study visit. The study is expected to screen and enroll over 3 months.IAVI G003 study participants will also be engaged in parallel socio-behavioral research to understand the acceptability of sampling techniques - fine needle aspiration (FNA), leukapheresis, and blood draws - used in the trial and the impact of trial participation on individuals and their communities. See more in the Moderna press release here.Last updated June 10, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Arms and Assigned Interventions
Description2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart
Mode of Delivery
Official Code: NCT05414786
Start Date
End Date
May 23, 2022
June 30, 2023
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women