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RV 144

Status
Completed
Phase
III
Principal Investigator(s)
Supachai Rerks-Ngarm
Objective


To determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

Results: The ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand.

Last updated September 14, 2022

Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
ALVAC-HIV vCP1521 + AIDSVAX 1cc injected into left deltoid muscle at day 0,weeks 4, 12, 24 Prime/Boost Vaccination
Mode of Delivery
Intramuscular
Products
AIDSVAX
ALVAC
ARMs
Experimental
Clade
B
E
Description
1cc ALVAC Placebo in left deltoid at day 0 and week 4 1 cc ALVAC Placebo + AIDSVAX Placebo in left deltoid on weeks 12 and 24
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Results
Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand
Official Code
NCT00223080
Related Publications
Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand
Vaccine-induced IgG antibodies to V1V2 regions of multiple HIV-1 subtypes correlate with decreased risk of HIV-1 infection
Analysis of HLA A*02 association with vaccine efficacy in the RV144 HIV-1 vaccine trial
CD8 and CD4 epitope predictions in RV144: no strong evidence of a T-cell driven sieve effect in HIV-1 breakthrough sequences from trial participants
Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials
Characterization of HIV-1 gp120 antibody specificities induced in anogenital secretions of RV144 vaccine recipients after late boost immunizations
Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans
Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults
Antibody-dependent cell-mediated cytotoxic responses in participants enrolled in a phase I/II ALVAC-HIV/AIDSVAX B/E prime-boost HIV-1 vaccine trial in Thailand
Foundations for a Phase III human immunodeficiency virus vaccine trial: A decade of Thai-U.S. Army collaborative research
Similar Trials
RV 305
RV 262
RV 306
Trial Sponsors
US Military HIV Research Program; Walter Reed Army Institute of Research (WRAIR); Sanofi Pasteur MSD; VaxGen; The EMMES Corporation; Ministry of Health, Thailand; Mahidol University; Royal Thai Army; Henry M Jackson Foundation
October 2003
June 2009
Date of Enrollment Completion
July 1, 2006
Enrollment
16 402
18
Years
30
Years
Population
Men
Women
Sites

Bang Lamung District Hospital

Chon Buri
Thailand

Phan Thong District Hospital

Chon Buri
Thailand

Sattahip District Hospital

Sattahip District, Chon Buri
Thailand

Ao Udom Hospital

Sri Racha District, Chon Buri
Thailand

Ban Chang District Hospital

Ban Chang District, Rayong
Thailand

Ban Khai District Hospital

Ban Khai District, Rayong
Thailand

Klaeng District Hospital

Klaeng District, Rayong
Thailand

Provincial Health Office

Muang District, Rayong
Thailand