New HIV vaccine combo enters first human safety trial
NCT ID NCT06905275
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
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 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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.
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The places running it
4 sites. 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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Alabama CRS (#31788)
Birmingham, Alabama, 35222, United States
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Columbia P&S CRS (#30329)
New York, New York, 10032, United States
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University of Rochester Medical Center
Rochester, New York, 14642, United States
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Vanderbilt Vaccine (VV) CRS (#30352)
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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