A5422: CH505 TF chTrimer Vaccination in Adults Living with HIV-1 on Suppressive ART

Treatment Experienced

This study is looking to see if an investigational anti-HIV vaccine (stabilized CH505 TF chTrimer) is safe and well-tolerated in people living with HIV on antiretroviral therapy whose viral load is <200 copies/mL The vaccine will be given five times over one year. The injection will be given similar to a flu shot, but in both of the upper arms at each vaccine visit.

Why is this study being done?

• To see if the anti-HIV vaccine is safe and well-tolerated
• To find out if the vaccine can help the immune system work against HIV

Who can join?

• People living with HIV aged 18 and older
• On stable HIV treatment for at least 2 years
• Current CD4 cell count greater than 200 copies/mL
• HIV viral load of less than 200 copies/mL for the past year
• No current Hepatitis B or C infection
• Generally healthy (no immune system disorders or HIV-related infections or cancers)

Participants will have a 2 in 3 chance of receiving the active vaccine (Arm 1) and a 1 in 3 chance of getting a placebo (Arm 2). Participants will not know if they are enrolled in Arm 1 or 2:

• Arm 1: Stabilized CH505 TF chTrimer vaccine at weeks 0, 8, 16, 32, and 52
• Arm 2: Placebo at weeks 0, 8, 16, 32, and 52

 

The vaccine or placebo will be injected into the muscle of each upper arm.

 

Participants will keep a symptom and medication diary for ten days after each vaccine dose. There are 13 visits over 100 weeks and blood draws will be done at all visits.

 

At three visits, an optional leukapheresis will be done. Leukapheresis involves taking blood from a vein in one arm, passing it through a machine that removes some of the cells, and returning the remaining blood back into a vein in the other arm. Participants who do not have leukapheresis will have a large volume blood draw.

Participants will receive the anti-HIV vaccine (stabilized CH505 TF chTrimer) or placebo through the study. They will continue to receive their anti-HIV medications by prescription.

 

Participants will be on study for about 2 years (100 weeks).