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Experimental HIV vaccine trial aims to boost immunity in people on suppressive therapy

NCT ID NCT06680479

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 1 trial tests a new therapeutic HIV vaccine (CH505 TF chTrimer) in 30 adults living with HIV who are on suppressive antiretroviral therapy. The vaccine is designed to stimulate the immune system to produce new antibodies against HIV. The study is currently suspended and focuses on safety and whether the vaccine can trigger a meaningful immune response.

What this could mean

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

Active substance
CH505 TF chTrimer vaccine with 3M-052-AF and aluminum hydroxide adjuvant
What this could lead to
If successful, this could point toward a way to train the immune system to better control HIV, potentially reducing reliance on daily antiretroviral therapy.
What could go wrong
This is a very early phase 1 trial with only 30 participants, so safety and immune response are still unknown. The trial is currently suspended, and many early vaccines fail to show enough benefit.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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.

Inclusion Criteria: * HIV-1 infection * On a suppressive ART regimen for at least 24 months with no changes in the 90 days prior to study entry * CD4+ cell count greater than 200 cells/mm3 obtained within 56 days prior to study entry * HIV-1 RNA \<200 copies/mL obtained within 56 days prior to study entry * Plasma HIV-1 RNA levels \<200 copies/mL for at least 12 months on ART prior to study entry * The following laboratory values obtained within 56 days prior to study entry * White blood cell count ≥2,500 cells/mm3 * Absolute neutrophil count (ANC) \>750/mm3 * Hemoglobin ≥11 g/dL for cisgender men/transgender women and ≥10 g/dL for cisgender women/transgender men * Platelet count ≥100,000/mm3 * Creatinine \<1.5x upper limit of normal (ULN) * Alanine aminotransferase (ALT) (SGPT) ≤1.5 ULN * Hepatitis C Virus (HCV) antibody-negative or HCV RNA negative result if indicated, within 56 days prior to study entry * Negative hepatitis B surface antigen (HBsAg) result obtained within 56 days prior to study entry * For study candidates of child-bearing potential, negative serum or urine pregnancy test at screening and within 48 hours prior to study entry * No participation in conception process and agree to use at least one reliable form of contraception if participating in sexual activity that could lead to pregnancy during the study and for 8 weeks following the final study vaccine Exclusion Criteria: * Known to have started ART during acute HIV infection * Known to have HIV-related opportunistic infections within the last 2 years prior to study entry. * History of malignancy within the last 5 years prior to study entry. * Currently breastfeeding * History of or active autoimmune disorders * HIV vaccination (prophylactic and/or therapeutic) within 1 year prior to study entry * Receipt of any anti-HIV-1 bNAbs within 2 years prior to study entry * Vaccination within 4 weeks prior to study entry * Use of any infusion blood product or immune globulin within 16 weeks prior to study entry (Exception: COVID-19-specific monoclonal antibodies are allowed) * Use of systemic immunomodulators, systemic cytotoxic chemotherapy, or non-FDA approved investigational therapy within 60 days prior to study entry * Intent to use immunomodulators during the course of the study * Immune deficiency other than HIV * HCV antiviral therapy within 90 days prior to screening * Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation * Active drug or alcohol use or dependence that would interfere with adherence to study requirements * Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry * Conditions that would preclude injection site reaction assessments (e.g., extensive tattoos, scarring, skin conditions).

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Case CRS

    Cleveland, Ohio, 44106, United States

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599-7215, United States

  • Cincinnati CRS

    Cincinnati, Ohio, 45267-0405, United States

  • Columbia Physicians & Surgeons (P&S) CRS

    New York, New York, 10032, United States

  • Harbor University of California Los Angeles Center CRS

    Torrance, California, 90502-2052, United States

  • Houston Advancing Research Team CRS

    Houston, Texas, 77030, United States

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114, United States

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103, United States

  • Northwestern University CRS

    Chicago, Illinois, 60611, United States

  • Ohio State University CRS

    Columbus, Ohio, 43210, United States

  • Penn Therapeutics CRS

    Philadelphia, Pennsylvania, 19104, United States

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012, United States

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103, United States

  • University of California, Los Angeles CARE Center CRS

    Los Angeles, California, 90035, United States

  • University of California, San Francisco HIV/AIDS CRS

    San Francisco, California, 94110, United States

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045, United States

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Adult HIV Therapeutic Strategies Network CRS

    Rochester, New York, 14642, United States

  • University of Washington Positive Research CRS

    Seattle, Washington, 98104, United States

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204, United States

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Chelsea CRS

    New York, New York, 10010, United States

  • Weill Cornell Uptown CRS

    New York, New York, 10065, United States

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