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Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

NCT07054931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ChAdOx1.tHIVconsv1

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

BIOLOGICAL

ChAdOx1.HIVconsv62

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

BIOLOGICAL

MVA.tHIVconsv4

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

BIOLOGICAL

GS-5423

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

BIOLOGICAL

GS-2872

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

OTHER

Treatment interruption induced viraemia

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

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054931 on ClinicalTrials.gov