CH505 TF chTrimer Vaccine for HIV Prevention

Palo Alto (17 mi)

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 trial tests a new vaccine called CH505 TF chTrimer in healthy adults. The vaccine is combined with substances to see if it helps the immune system produce strong antibodies. The goal is to ensure the vaccine is safe and effective.

Eligibility Criteria

Healthy adults aged 18-55 who are not pregnant, breastfeeding, or at high risk for HIV. Participants must be in good health, available for follow-up visits, willing to undergo certain medical procedures like lymph node aspiration and leukapheresis, and agree to use effective birth control. Exclusions include recent receipt of blood products or certain vaccines, serious vaccine reactions, asthma requiring frequent steroid use or emergency care, immune-mediated diseases, drug abuse history.

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks.

Treatment Details

The trial is testing the CH505 TF chTrimer vaccine with different doses of the adjuvants 3M-052-AF and Alum to evaluate safety and how well it generates an immune response (immunogenicity). Part A uses a specific dose combination while Part B tests varying doses/combinations to find the best balance between effectiveness and side effects.

4Treatment groups

Experimental Treatment

Group I: Group 4: TreatmentExperimental Treatment2 Interventions

CH505 chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group II: Group 3: TreatmentExperimental Treatment3 Interventions

CH505 cTrimer, 300 mcg admixed with (3 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide Ssuspension (Alum) administered at months 0, 2, 4, 8 and 12.

Group III: Group 2: TreatmentExperimental Treatment2 Interventions

CH505 TF chTrimer 300 mcg admixed with (3 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group IV: Group 1:TreatmentExperimental Treatment3 Interventions

CH505 TF chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide suspension, administered at months 0, 2, 4, 8 and 12.