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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.

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
Similar Trials
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
Enrollment
16 402
18
Years
30
Years
Population
Women
Men
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