drugset / Trial / NCT07054931

Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

NCT07054931

Phase 2 Recruiting 48 enrolled University of Oxford
RandomizedParallel-groupOpen-labelTreatment

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 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.

Timeline

Start
2025-09-05
Primary completion
2027-10-31
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator ChAdOx1.HIVconsv62 Vaccine 2.5e+10 unknown Other
Comparator ChAdOx1.tHIVconsv1 Vaccine 2.5e+10 unknown Other
Comparator MVA.tHIVconsv4 Vaccine 1e+08 unknown Other
Comparator Teropavimab Monoclonal antibody 2550 mg Other
Comparator Zinlirvimab Monoclonal antibody 850 mg Other