Phase 1 Study of GRAdHIVNE1 Vaccine for Adults With and Without HIV in Southern Africa

What this Trial Is About

Researchers are conducting a Phase 1 trial to study the GRAdHIVNE1 vaccine, which uses a gorilla adenovirus vector to target HIV. The study aims to evaluate the vaccines safety, tolerability, and ability to stimulate immune responses in healthy adults both living with and without HIV. This trial builds on earlier vaccine research and preclinical studies that highlighted the importance of broad T-cell responses for controlling HIVs diversity and immune evasion. Participants living without HIV will be randomly assigned to receive either one or two doses of the GRAdHIVNE1 vaccine at two possible dose levels or a placebo. Those living with HIV will receive either two doses of the vaccine or placebo. The vaccine doses studied are 5x1010 or 2x1011 units. The study uses a double-blind design to compare vaccine effects with placebo. Throughout the study, participants will be closely monitored for safety and side effects over several timeframes including 7 days, 28 days, and up to 19 months. Immune responses will be measured repeatedly for up to 19 months to assess the vaccines impact. Participants will complete follow-up visits to evaluate adverse events, immune function, and overall health status during the trial period.

A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.