RecruitingPhase 2NCT07054931

Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

AbVax: Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV to Induce a Protective T-cell 'Vaccinal Effect' - a Randomised Phase II Clinical Trial


Sponsor

University of Oxford

Enrollment

48 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of an HIV vaccine and broadly neutralising antibodies (bNAbs) — powerful lab-made proteins that can attack many strains of HIV — in people living with HIV who are stable on antiretroviral therapy. The goal is to train and strengthen the immune system so it can potentially keep the virus suppressed if antiretroviral therapy is paused. **You may be eligible if...** - You are 18–64 years old and living with HIV - You have been on stable antiretroviral therapy for at least a year with an undetectable viral load - Your immune cell count (CD4) is above 500 or your CD4:CD8 ratio is greater than 1.0 - You are in otherwise good health with no major co-existing illnesses - You are on an integrase inhibitor or boosted protease inhibitor regimen **You may NOT be eligible if...** - Your HIV viral load has not been consistently suppressed - Your immune cell counts are too low - You have significant co-existing illnesses or are immunocompromised for other reasons - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALChAdOx1.tHIVconsv1

solution for injection one dose of 2.5 x 10\^10 vp/ml Arm B and Arm C

BIOLOGICALChAdOx1.HIVconsv62

solution for injection one dose of 2.5 x 10\^10 vp/ml Arm B and Arm C

BIOLOGICALMVA.tHIVconsv4

suspension for injection two doses of 1 x 10\^8 vpu/ml Arm B and Arm C

BIOLOGICALGS-5423

Solution for infusion 2550 mg Arm A, Arm B and Arm C

BIOLOGICALGS-2872

Solution for infusion 850 mg Arm A, Arm B and Arm C

OTHERTreatment interruption induced viraemia

Participants pause ART before receiving vaccines and/or bNAbs Arm A and Arm C


Locations(3)

Guys and St Thomas' NHS Trust

London, United Kingdom

St Mary's Clinical Trial Unit

London, United Kingdom

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07054931


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