AbVax
Research type
Research Study
Full title
AbVax: Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV to induce a protective T-cell ‘vaccinal effect’ - a randomised phase II clinical trial
IRAS ID
1009920
Contact name
Paola Cicconi
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics and Assurance
Research summary
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 last longer - one dose can last 6 months. The impact of long-term tablet-free remission for people living with HIV (PWH) is enormous, particularly for remote groups and countries with less developed health infrastructures. 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 long-term protection for PWH. We think that 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 blood stream) and bNAbs will produce the most sustained immune protection. AbVax will recruit 53 otherwise healthy PWH aged 18-64. They will be randomised across three groups (arms) to determine the best combination. In Arm A, participants undergo TIIV, then receive two bNAb infusions. In Arm B, participants receive a combination of three HIV vaccines (one prime dose, followed by two booster doses after 4 and 16 weeks), then are given two bNAb infusions. In Arm C, participants undergo TIIV, receive the same HIV vaccinations as Arm B, then are given two bNAb infusions. All participants then stop ART for an analytical treatment interruption (ATI) to determine the clinical impact and measure how long before any HIV returns to the blood. This allows us to see if vaccines and TIIV add to protection provided by bNAbs and by how much. Regular monitoring visits and vaccinations will take place at the participant’s normal HIV clinic. bNAb infusions will take place at Hammersmith Hospital, London or CCVTM, Oxford.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0136
Date of REC Opinion
9 Apr 2025
REC opinion
Further Information Favourable Opinion