NCT06617091

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

A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa

Detailed description

This is a Phase 1 trial for the GRAdHIVNE1 vaccine, designed to evaluate safety, tolerability, and immunogenicity in healthy individuals (PLWoH) including healthy People Living with HIV (PLWH). This study builds on insights from prior T-cell vaccine trials and pre-clinical non-human primate studies, which demonstrated that robust CD8+ T cell responses, are crucial for viral control but require broad, polyfunctional responses that can also effectively counteract HIV's diversity and immune evasion strategies. Inclusion of PLWoH and PLWH in this study is important for safety, tolerability and immunogenicity data that can inform further development of the vaccine for prevention and therapeutic use. Prior clinical trials, using adenovirus vectors and exploring different vaccine approaches, demonstrated safety and potential immunogenic benefits in PLWH, despite not achieving sustained viral suppression post-treatment interruption Understanding these dynamics is key to evaluating the full therapeutic potential of vaccine induced immune responses in controlling HIV as well as inform the potential of the vaccine in aborting the establishment of a disseminated infection in the setting of prevention.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	GRAdHIVNE1 Vaccine	This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.
OTHER	Placebo	This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.

Timeline

• Start date: 2025-07-28
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-09-27
• Last updated: 2026-02-13

Locations

3 sites across 2 countries: South Africa, Zimbabwe