Could a vaccine combo free people with HIV from daily pills?
NCT ID NCT06071767
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 5 times
Summary
This study tests whether a special T-cell vaccine, combined with an immune-boosting drug (vesatolimod) and two powerful antibodies, can help people with HIV control the virus without needing daily antiretroviral therapy. The trial involves 36 adults who started HIV treatment soon after infection and have been on stable therapy for at least a year. Participants will receive the vaccine regimen or a placebo, then temporarily stop their regular HIV meds to see if the new approach keeps the virus in check.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- T-cell vaccine (ChAdOx1-MVA/HIVconsvX), vesatolimod, and broadly neutralizing antibodies (GS-5423, GS-2872)
- What this could lead to
- If successful, this could point toward a way for people with HIV to stop daily antiretroviral therapy while keeping the virus under control.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply broadly. The combination regimen is complex and may cause side effects or fail to control the virus.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Provision of written informed consent. * History of Initiation of combination ART within 90 days of acute HIV diagnosis * On ART for at least 12 months with no known ART interruption \>28 consecutive days within 12 months prior to Step 1 Study Entry * ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir/lamivudine regimen for at least 6 weeks prior to Study Entry. * Willingness to participate in the ATI and willingness to restart ART according to study guidelines. * Willingness to adhere to protocol therapy and complete all study visits. * Weight ≥50 kg and ≤150 kg at Screening. * CD4 cell count ≥450 cells/mm3 obtained within 60 days prior to Study Entry. * HIV-1 RNA \<50 copies/mL (or below the assay limit of quantification if local assay lower limit of quantification is \>50 copies/mL) for at least 1 year and within 60 days prior to Study Entry. * Select laboratory results within 60 days of study entry * For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry. * Participants who are able to become pregnant and who are engaging in sexual activity that could lead to pregnancy must agree to use two methods of contraception, one of which must be a highly effective methods for contraception. Barrier methods of contraception are required for the second method of contraception. * Availability of results of HLA typing (required for randomization). * Completion of pre-entry leukapheresis or LVBD. Exclusion Criteria * Currently pregnant or breastfeeding or planning to become pregnant during study participation. * Prior receipt of anti-HIV broadly neutralizing antibody therapy. * Receipt of any non-HIV monoclonal antibody therapy within 1 year prior to study entry. * Prior receipt of a latency-reversing agent (LRA). * Receipt of HIV-1 or other investigational vaccines within 6 months prior to Study Entry. * Receipt of a live-virus vaccine within 60 days or any vaccination within 14 days prior to Study Entry. * Receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222) within 12 months prior to Step 1 Study Entry. * Known allergy/sensitivity or any hypersensitivity to components of study treatments or their formulations. * Known severe chicken egg allergy. * Known history of a severe reaction or anaphylaxis to prior vaccinations or antibody preparations (e.g., intravenous immunoglobulin). * Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity). * Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema. * Previous or current history of bleeding factor deficiency, coagulopathy or platelet disorder or on chronic anticoagulation. * History of inflammatory neurologic diseases. * History of pregnancy, head trauma or major surgery within 90 days prior to Step 1 Study Entry. * History of use of any immunomodulatory medications within the 6 months prior to Step 1 Study Entry. * Significant serious skin disease, such as but not limited to active rash, eczema, psoriasis, or urticaria. * Autoimmune disease (e.g., lupus, multiple sclerosis, and others) requiring ongoing immunosuppression. * Known history of CDC Stage 3 opportunistic infection (OI). * Any history of an HIV-associated malignancy. * Known or suspected active or untreated latent Mycobacterium tuberculosis infection. * Active or recent non-HIV-associated malignancy. * Serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry. * Known resistance to one or more drugs in two or more ARV drug classes. * History of or current clinical atherosclerotic cardiovascular disease * Current advanced liver disease. * Use of complementary or alternative medicines within 14 days prior study entry.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 2 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chapel Hill CRS
Chapel Hill, North Carolina, 27599, United States
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Houston AIDS Research Team CRS
Houston, Texas, 77004, United States
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Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, Brazil
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Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Rio Grande do Sul, 91350-180, Brazil
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Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, 02114, United States
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Northwestern University CRS
Chicago, Illinois, 60611, United States
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Ohio State University CRS
Columbus, Ohio, 43210, United States
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Penn Therapeutics CRS
Philadelphia, Pennsylvania, 19104, United States
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Ponce de Leon Center CRS
Atlanta, Georgia, 30308, United States
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University of California, San Diego AntiViral Research Center CRS
San Diego, California, 92103, United States
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Washington University Therapeutics CRS
St Louis, Missouri, 63110, United States
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