Actively Recruiting
A Phase 1 Randomized Double-Blind Placebo-Controlled Dose Ranging Trial of the GRAdHIVNE1 Vaccine in Healthy Adults Living With and Without HIV in Southern Africa
Led by International AIDS Vaccine Initiative · Updated on 2026-02-13
120
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
R
Ragon Institute
Collaborating Sponsor
AI-Summary
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 vaccine's 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 HIV's 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 5x10^10 or 2x10^11 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 vaccine's impact. Participants will complete follow-up visits to evaluate adverse events, immune function, and overall health status during the trial period.
CONDITIONS
Brief Title
A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old and younger than 51 at consent
- Willing and able to follow study requirements and attend all follow-up visits
- Able to understand study information and provide written informed consent
- Women able to become pregnant must use effective contraception from 21 days before first dose until 4 months after last dose, unless surgically sterile or postmenopausal
- Willing to avoid donating blood or tissues during the study
- For participants living with HIV: confirmed HIV infection, CD4 count ≥ 500 cells/µl, on stable antiretroviral therapy for at least 12 months with viral load < 50 copies/ml
- Willing to maintain suppressive ART regimen throughout the study
- For participants without HIV: low risk of HIV infection and willing to maintain low-risk behavior during the trial
You will not qualify if you...
- Any serious acute or chronic medical condition aside from HIV that could affect safety or study participation
- For people with HIV: history of AIDS-defining illness or CD4 count < 200 cells/µl
- Pregnant, breastfeeding, or planning pregnancy during study period
- History of alcohol or substance use in past 6 months that could affect study compliance
- Diagnosed bleeding disorders requiring special precautions
- History of splenectomy
- Previous receipt of adenovirus vectored vaccine
- Recent live vaccine within 60 days before or planned within 180 days after study
- Recent blood transfusion within 3 months
- Participation in another clinical trial of investigational products currently or within past 3 months
- Previous investigational HIV vaccine or antibody treatment without medical monitor approval
- History of severe vaccine reactions (e.g. anaphylaxis)
- Psychiatric conditions affecting safety or compliance, including recent psychosis or suicide risk
- Recent seizures within 3 years
- Chronic hepatitis B or active hepatitis C or syphilis infection
- History of cancer within past 5 years or ongoing malignancy
- Active serious infections needing intravenous treatment within 30 days before enrollment
- Abnormal lab results considered clinically relevant
- Immunodeficiency or autoimmune diseases (other than HIV in PLWH), recent use of certain immune-affecting medications
- For participants without HIV: must be low risk for HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive either a single dose or two doses of the GRAdHIVNE1 vaccine or placebo, depending on HIV status and assigned group.
1 to 2 visits depending on assigned vaccine dose schedule
Duration - Up to 19 months
Participants are monitored for safety, tolerability, and immune response for up to 19 months after vaccination.
Multiple follow-up visits over 19 months
Trial Site Locations
Total: 3 locations
1
AHRI
Mtubatuba, KwaZulu-Natal, South Africa
Actively Recruiting
2
DTHF
Cape Town, Western Cape, South Africa
Actively Recruiting
3
Mutala
Harare, Harare, Zimbabwe
Actively Recruiting
Research Team
V
Vincent Muturi-Kioi, MBChB
L
Lebohang Molife, MBChB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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