Status:
SUSPENDED
A Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type HIV-1 Nanoparticle Vaccine (UVAX-1197) Boost, Each Adjuvanted With 3M-052-AF + Alum in Adult Participants Without HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institutes of Health (NIH)
Department of Health and Human Services
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time thi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06905275
Start Date
July 7 2025
End Date
July 20 2027
Last Update
September 4 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama CRS (#31788)
Birmingham, Alabama, United States, 35222
2
Columbia P&S CRS (#30329)
New York, New York, United States, 10032
3
University of Rochester Medical Center
Rochester, New York, United States, 14642
4
Vanderbilt Vaccine (VV) CRS (#30352)
Nashville, Tennessee, United States, 37232