RV 305

Status:Ongoing
Phase:II
Principal Investigator(s):Supachai Rerks-Ngarm, MD
Objective:Randomized, Double Blind Evaluation of Late Boost Strategies for HIV-uninfected Participants in the HIV Vaccine Efficacy Trial RV 144: "Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults". After two boosts (6 month interval) with the same immunogens 6-8 years after the completion of the RV144 primary immunization, plasma neutralizing antibody (nAb) responses were assayed. Result summary: Delayed and repetitive boosting of RV144 vaccine-recipients was capable of increasing somatic hypermutation of the Env-reactive antibodies and expanding subdominant pools of neutralizing B cell clonal lineages. Last updated September 14, 2022
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionALVAC-HIV + AIDSVAX B/E or ALVAC-HIV placebo + AIDSVAX B/E placebo at Weeks 0 and 24
Mode of Delivery
ARMsExperimental
DescriptionAIDSVAX B/E or AIDSVAX B/E placebo at Weeks 0 and 24
Mode of Delivery
ARMsExperimental
DescriptionALVAC-HIV or ALVAC-HIV placebo at Weeks 0 and 24
Mode of Delivery
ARMsExperimental
Results: Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial
Official Code: NCT01435135
Related Publications:
Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand
Boosting of HIV envelope CD4 binding site antibodies with long variable heavy third complementarity determining region in the randomized double blind RV305 HIV-1 vaccine trial
Boosting with AIDSVAX B/E Enhances Env Constant Region 1 and 2 Antibody-Dependent Cellular Cytotoxicity Breadth and Potency
HIV vaccine delayed boosting increases Env variable region 2–specific antibody effector functions
Trial Sponsors: NIH, USAMRDC
Start Date
End Date
April 1, 2012
July 2, 2021
Enrollment:162
Age range: 18 Years ↔ any
Population:Cisgender Men, Cisgender Women