ANRS VRI06

Main points

• The vaccine candidate “CD40.HIVRI.Env” is a monoclonal antibody that specifically targets CD40 receptors located on the surface of dendritic cells. The antibodies are coupled with HIV envelope antigens in order to deliver the antigen directly to dendritic cells and generate a strong immune response.
• The ANRS VRI06 trial aims to evaluate this vaccine candidate in 72 healthy volunteers. It is a phase I, multicenter, double-blind, placebo-controlled, dose-escalation trial conducted in France and Switzerland to evaluate different doses (0.3, 1, and 3 mg) of the CD40.HIVRI. Env adjuvanted with Hiltonol®, administered alone (Solo groups) or co-administered with the DNA-HIV-PT123 vaccine (Combi groups) at weeks W0, W4, and 24. Participants will be randomized into one of the six trial groups to receive the active vaccine strategy or placebo in a 5:1 ratio. Enrollment in a given group (other than the “Solo 0.3” group) will be opened based on criteria derived from safety data from the previous group(s).
• An additional booster dose (part 2 of the trial) will be administered late (Late Boost of CD40.HIVRI.Env post W48) and follow-up will be conducted 2 weeks (WLB+02) and 24 weeks (WLB+24) after the “Boost” (WLB). Volunteers (n=60) who received the active vaccination in part 1 of the trial will be randomized in a single-blind manner to receive a 0.3 mg dose of the CD40.HIVRI.Env vaccine, either with or without adjuvant.