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
Purpose
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 this combination of study products is being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health. Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Condition
- HIV-1-infection
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- The trial will begin with enrollment of Group 1. Groups 2 and 3 will open to enrollment concurrently. Enrollment in Group 2 and Group 3 will be randomized.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 |
Treatment: 150 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum, to be administered at Weeks 0 and 8. Followed by: 150 mcg of UVAX-1197 admixed with of 5 mcg of 3M-052-AF + 500 mcg Alum to be administered at Weeks 20 and 32. |
|
|
Experimental Group 2 |
Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 0 and 8. Followed by: 300 mcg of UVAX-1197 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 20 and 32. |
|
|
Experimental Group 3 |
Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be at Weeks 0, 8, 20, and 32. |
|
Recruiting Locations
Alabama CRS (#31788)
Birmingham 4049979, Alabama 4829764 35222
Birmingham 4049979, Alabama 4829764 35222
Columbia P&S CRS (#30329)
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Vanderbilt Vaccine (VV) CRS (#30352)
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
More Details
- NCT ID
- NCT06905275
- Status
- Recruiting
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)