Actively Recruiting
A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.
Led by International AIDS Vaccine Initiative · Updated on 2026-02-13
120
Participants Needed
3
Research Sites
87 weeks
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
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
CONDITIONS
Official 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...
- Adults aged 18 to 50 years at screening
- Willing to follow study requirements and available for follow-up
- Able to give informed consent after understanding the study
- Sexually active females capable of pregnancy must agree to 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 tissue during the study
- For people living with HIV: confirmed HIV infection with CD4 count ≥ 500 cells/µl
- For people living with HIV: on continuous combination ART for at least 12 months with viral load < 50 copies/ml for over 6 months
- For people living with HIV: viral load < 50 copies/ml at screening
- For people living with HIV: agree to maintain suppressive ART during the study
- People living without HIV must be at low risk for HIV infection and willing to maintain low-risk behavior during the trial
You will not qualify if you...
- Any significant medical condition (other than HIV in PLWH) judged progressive or unsuitable by investigator
- For PLWH: history of AIDS-defining illness or CD4 count < 200 cells/µl
- Pregnant, breastfeeding, or planning pregnancy during screening through study completion
- History of alcohol or substance use in past 6 months that may affect study compliance
- Diagnosed bleeding disorders requiring precautions
- History of splenectomy
- Previous adenovirus vectored vaccine receipt
- Receipt of live or other vaccines within 60 days before or planned within 180 days after study drug
- Blood transfusion or blood products within 3 months
- Participation in another investigational product trial within 3 months or planned during study
- Prior investigational HIV vaccine, monoclonal antibody, or immunoglobulin treatment except placebo with approval
- History of severe vaccine reactions (e.g., anaphylaxis)
- Psychiatric conditions compromising safety or compliance, including recent psychosis or suicide risk
- Investigator judgment deeming participation not in participant's best interest
- Seizure disorder with seizures in past 3 years
- Chronic hepatitis B or current hepatitis C infection or recent treatment
- Active syphilis infection
- History of cancer within past 5 years or ongoing malignancy
- Active serious infections needing intravenous treatment within 30 days
- Abnormal lab tests per protocol
- History of immunodeficiency or autoimmune disease (except HIV in PLWH) or recent use of immunosuppressive drugs within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Lebohang Molife, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here