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Can a vaccine cocktail free HIV patients from daily pills?

NCT ID NCT04357821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This early-phase trial tests whether a combination of two experimental vaccines, an immune booster, and two powerful antibodies can help people with HIV control the virus after stopping their daily antiretroviral therapy. Eleven participants will receive the regimen while on ART, then pause their regular medication to see if the virus stays at bay. The goal is to achieve a lasting remission, not a cure, as the virus may still be present but kept under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
combination of DNA vaccine, MVA vaccine, TLR9 agonist (lefitolimod), and broadly neutralizing antibodies (VRC07-523LS and 10-1074)
What this could lead to
If it works, this could point toward a way for people with HIV to stop daily antiretroviral therapy and keep the virus under control for months or longer.
What could go wrong
This is a very small, early-phase study with only 11 participants, so results may not apply widely. The combination is complex and could cause side effects, and there is no guarantee of achieving remission.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

11 people

The number who actually took part.

Started

Aug 2020

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 67 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria 1. Willing and able to provide written informed consent. 2. Age ≤67 years at the time of enrollment for those who started treatment during early infection and \<65 years for those who started treatment during chronic infection. 3. Documented HIV-1 infection. 4. On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days within the last 1 year, and on a stable regimen that does not include an non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks, without plans to modify ART during the study period. 5. Screening plasma HIV RNA levels below the level of quantification on all available determinations in past 24 months. 6. Screening CD4+ T-cell count ≥ 500 cells/mm3. Key Exclusion Criteria 1. Subjects receiving a non-nucleoside reverse transcriptase inhibitor 2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences). 4. Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers. 5. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months. 6. CD4+ T cell nadir \<350 cells/mm3 during the chronic phase of infection (beginning 6 months following the estimated infection date and confirmed on repeat testing). 7. Active hepatitis B (HBV) infection defined as positive HBV surface antigen test. 9\. Active hepatitis C (HCV) infection. 10. Presence of significant abnormalities on electrocardiogram. 11. History of potential immune-mediated medical conditions. Individuals with isolated Raynaud's phenomenon or localized disease requiring topical therapy alone will not be excluded.

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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.

Contacts and locations

Locations

  • Zuckerberg San Francisco General Hospital, University of California San Francisco

    San Francisco, California, 94110, United States

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Other studies related to the condition(s) this trial covers.