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New HIV vaccine combo enters first human safety trial

NCT ID NCT06905275

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This early-stage trial tests two experimental HIV vaccines, UVAX-1107 and UVAX-1197, in 25 healthy adults without HIV. The goal is to check if the vaccines are safe and whether they trigger an immune response. Participants will receive injections and be followed for about a year.

What this could mean

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

Active substance
UVAX-1107 and UVAX-1197 vaccines with 3M-052-AF + alum adjuvant
What this could lead to
If successful, this could point toward a safe and effective HIV vaccine that trains the immune system to fight the virus.
What could go wrong
This is a very early Phase 1 trial with only 25 people, so it is too soon to know if the vaccines will work. The study is also currently suspended, and side effects are possible.

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 25 people

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

Started

Jul 2025

Expected to finish

Jul 2027

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 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Understand the study and agree to participate. * Be available for follow-up visits and contact for 12 months after the last study product is administered. * Be willing to undergo all study procedures. * Not be in another study unless approved by both study sponsors. * Be in good general health. * Have normal physical exam and lab results. * Agree to discuss HIV risk and prevention. * Have a certain minimum hemoglobin level (≥ 11.0 g/dL for women, ≥ 13.0 g/dL for men). * Have a white blood cell count within 2500 to 12,000/mm³. * Have a platelet count between 125,000 to 550,000/mm³. * Have an ALT level less than 2.5 times the upper limit of normal. * Have a serum creatinine level within 1.1 times the normal limit. * Have a serum calcium level of at least 8.5 mg/dL. * Have blood pressure within specified limits. * Test negative for HIV. * Test negative for Hepatitis C. * Test negative for Hepatitis B. * Women who can become pregnant must use effective contraception and test negative for pregnancy at enrollment. * Women who can become pregnant must agree not to seek pregnancy through alternative methods during the study period. Exclusion Criteria: * Breastfeeding or pregnant. * BMI is 40 or higher (exceptions can be made if you're in good health). * Diagnosed with diabetes (unless it's well-controlled Type 2 diabetes or gestational diabetes). * Received an investigational HIV vaccine or monoclonal antibodies. * Received a non-HIV investigational vaccine in the past year (exceptions exist for licensed or emergency-authorized vaccines). * Have an immune deficiency or are taking medications that impair immune response. * Received blood products or immunoglobulins within the last 16 weeks. * Received certain vaccines within 4 weeks before enrollment. * Received other vaccines within 14 days before enrollment. * Started allergy immunotherapy within the last year (stable therapy is okay). * Taken investigational research agents recently. * Had a serious reaction to any vaccine. * Have hereditary or acquired angioedema. * Had unexplained hives in the past year. * Have a bleeding disorder that would make study procedures risky. * Had seizures or taken seizure medication in the past 3 years. * Spleen has been removed or spleen doesn't work properly. * Active duty or reserve US military personnel. * Any serious health condition that could affect safety, rights, or ability to participate (including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential recurrence). * Asthma that requires frequent or high-dose medication, emergency care, or multiple maintenance therapies. * History of certain immune-mediated medical conditions (mild, localized conditions may be okay). * Allergic to local anesthetics like Novocaine or Lidocaine. * History of difficult venous access or intravenous drug use.

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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.

  1. The places running it

    4 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

  • Alabama CRS (#31788)

    Birmingham, Alabama, 35222, United States

  • Columbia P&S CRS (#30329)

    New York, New York, 10032, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Vanderbilt Vaccine (VV) CRS (#30352)

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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