Health TrialsbyHealthPanel

Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

ConditionHIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Oxford

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

PWH aged ≥18 to ≤64 years old at screening

Able to give informed written consent including consent to long-term follow-up

Willing and able to comply with visit schedule and provide blood sampling

Willing to consent to their HIV care team being informed of their participation and sharing relevant clinical information

Disqualifiers

• Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk >20, stable angina, unstable angina, stroke)

Any current or past history of malignancy, excluding squamous cell skin cancers

Concurrent opportunistic infection or other co-morbidity likely to occur during the trial e.g.

Any contraindication to receipt of BHIVA recommended combination antiretrovirals

Trial design

Design model

Parallel

Treatments tested in this trial

  • ChAdOx1.tHIVconsv1

    Biological/Vaccine

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

  • ChAdOx1.HIVconsv62

    Biological/Vaccine

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

  • MVA.tHIVconsv4

    Biological/Vaccine

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

  • GS-5423

    Biological/Vaccine

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

  • GS-2872

    Biological/Vaccine

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

  • Treatment interruption induced viraemia

    Other intervention

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

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Arm AActive comparator 3 interventions
Group B: Arm BActive comparator 5 interventions
Group C: Arm CActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Fold change in T cell immune response to the HIV Gag protein

The geometric mean of the fold-change (GMFC) will be compared between Arm C compared to Arm A; and Arm C compared to Arm B.

Time frame
Baseline and 12 weeks after ATI

Secondary outcomes

1

Safety Assessment

Occurrence of Serious Adverse Events for the whole study duration.

Time frame
From enrollment until 16 weeks after restarting ART after ATI
2

Safety Assessment

Number of participants with adverse events (not including SAEs)

Time frame
From enrollment until 16 weeks after ART restart after ATI
3

HIV viral control

% of participants with undetectable plasma viral load

Time frame
Weeks 12 and weeks 24 after ATI
4

Immunological correlation of virological remission

CD4 T cell counts and CD8:CD4 ratios

Time frame
Week 12 and week 24 after ATI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Source ClinicalTrials.gov
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