HIV Vaccine for HIV Prevention

Recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for 25 healthy adult volunteers without HIV. Participants will be involved in the study for about a year, with clinic visits and follow-up contact after the final injection to monitor their health.

Inclusion Criteria

Have a white blood cell count within 2500 to 12,000/mm³

Be in good general health

Agree to discuss HIV risk and prevention

Exclusion Criteria

I have a genetic or developed condition causing swelling attacks.

Had unexplained hives in the past year

I have a bleeding disorder that could make medical procedures dangerous for me.

Treatment Details

Interventions

• UVAX-1107 (Cancer Vaccine)
• UVAX-1197 (Cancer Vaccine)

Trial Overview The trial tests two HIV-1 nanoparticle vaccines, UVAX-1107 and UVAX-1197, both enhanced with an adjuvant called 3M-052-AF + Alum. It's a phase 1 trial to assess safety, comfort during administration, and immune response.

Participant Groups

Group I: Group 3 Experimental Treatment 2 Interventions

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.

Group II: Group 2 Experimental Treatment 3 Interventions

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.

Group III: Group 1 Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+