Actively Recruiting
Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV
Led by University of Oxford · Updated on 2026-01-21
48
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is no cure for HIV infection. Antiretroviral therapy (ART) is widely available but requires daily, life-long intake. This can cause issues around side-effects, resistance, adherence and stigma. A new therapy, broadly neutralising antibodies, (bNAbs), may work as well as ART and may last longer - one dose can last six months. bNAbs appear to first target HIV viruses, then drive a protective immune response conferring long-term control, called the vaccinal effect. AbVax is a clinical trial to understand this effect and how to enhance it to give the strongest possible long-term protection for people living with HIV (PWH). The investigators are studying whether a combination of vaccines that attack HIV, a short period of treatment interruption induced viraemia (TIIV - stopping ART for a few weeks to allow a small amount of virus to return to the bloodstream) and bNABs will produce the most sustained immune protection.
CONDITIONS
Official Title
Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People living with HIV aged 18 to 64 years at screening
- Able to provide informed written consent including long-term follow-up
- Willing and able to follow visit schedule and provide blood samples
- Agree for their HIV care team to be informed and share relevant clinical information
- Stable on oral ART with suppressed undetectable HIV viral load for at least 1 year
- No viral resistance to GS-2872 based on proviral sequencing
- No significant co-morbidities as judged by the investigator
- Nadir CD4 count above 200 cells/µl unless treatment started during acute infection
- Current CD4 count above 500 cells/µl or CD4:CD8 ratio over 1.0
- On integrase inhibitor or boosted protease inhibitor regimen at randomisation
- If previously on NNRTI, switched at least 4 weeks before randomisation
- Adequate haemoglobin levels (≥12 g/dL males, ≥11 g/dL females)
- Weight at least 50 kg
- Received at least 3 COVID-19 vaccine doses, last at least 4 weeks before randomisation
- Received current seasonal influenza vaccination during September-April
- People able to become pregnant must agree to use effective contraception or abstinence from 2 weeks before first IMP dose until 20 months after last IMP dose and viral suppression
- Agree to take precautions to prevent HIV transmission while off ART or with detectable viral load
You will not qualify if you...
- Previous ischemic heart disease or stroke
- Any current or past cancer except squamous cell skin cancer
- Concurrent opportunistic infection or co-morbidities likely during trial (e.g., malabsorption, autoimmune disease)
- Contraindications to BHIVA recommended antiretrovirals
- Current treatment with injectable ART
- HTLV-1 co-infection
- Major antiretroviral resistance mutations
- Hepatitis B infection requiring treatment
- Hepatitis C infection
- High risk for severe COVID-19 as per physician
- Current or planned systemic immunosuppressive therapy (inhaled/topical corticosteroids allowed)
- Recent or planned participation in other investigational medicinal product trials
- History of severe allergic reactions to antibody infusions or vaccines
- History of thrombosis-related syndromes or clotting disorders
- Known anti-PF4 antibody positivity
- Planned treatment with IV immunoglobulin or monoclonal antibodies during trial
- Significant abnormal blood tests including liver impairment, high ALT, low kidney function, high urine protein, or clotting abnormalities
- Organ dysfunction or significant clinical abnormalities preventing enrolment
- Active alcohol or substance use preventing adherence
- Insufficient venous access for blood draws
- Concerns about adherence to HIV transmission precautions during treatment interruption
- Pregnancy, breastfeeding, or intending pregnancy
- Unable to be followed closely due to geographic, social, or psychological reasons
- Unable to understand written or verbal English to consent appropriately
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Guys and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
2
St Mary's Clinical Trial Unit
London, United Kingdom, W2 1NY
Actively Recruiting
3
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, United Kingdom, OX3 7LJ
Actively Recruiting
Research Team
P
Paola Cicconi, MD, PhD
CONTACT
J
John Frater, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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