CH505 TF chTrimer Vaccine for HIV Prevention

Recruiting at 2 trial locations

Overseen By Lindsey Baden, M.D.

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.

Research Team

Kenneth H Mayer, M.D.

Principal Investigator

Beth Israel Deaconess Medical Center

Lindsey R Baden, M.D.

Principal Investigator

Brigham and Women's Hospital

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.

Inclusion Criteria

Negative for Hepatitis B surface antigen

Negative results for HIV infection by an FDA-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA)

I do not have hepatitis C.

Exclusion Criteria

History of allergy to local anesthetic

I haven't taken any experimental drugs with a short half-life in the last 4 weeks.

I received the Monkeypox vaccine within the last 30 days.

Treatment Details

Interventions

• CH505 TF chTrimer (Virus Therapy)

Trial Overview 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.

Participant Groups

Group I: Group 4: Treatment Experimental Treatment 2 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: Treatment Experimental Treatment 3 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: Treatment Experimental Treatment 2 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:Treatment Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+