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RV 306

Status
Ongoing
Phase
II
Principal Investigator(s)
Punnee Pitisuttithum, MD, DTM&H
Objective
The primary purpose of the study is to better define the relative contributions of AIDSVAX® B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune profile in the weeks and months after receiving the original prime and boost vaccine regimen from study protocol RV 144, and their booster effects in both the systemic and mucosal compartments. In addition, this study will provide more intensive and comprehensive characterization of the innate, cell-mediated and humoral immune responses than possible within the RV 144 study. *Analysis for trial is ongoing*
Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Mode of Delivery
Intramuscular
Products
AIDSVAX
ALVAC
ARMs
Experimental
ARMs
Placebo Comparator
Description
ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48
Mode of Delivery
Intramuscular
Products
AIDSVAX
ALVAC
ARMs
Experimental
Description
ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24; AIDSVAX B/E at Week 48
Mode of Delivery
Intramuscular
Products
AIDSVAX
ALVAC
ARMs
Experimental
Description
ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24; AIDSVAX B/E Placebo at Week 48
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
ALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Mode of Delivery
Intramuscular
Products
AIDSVAX
ALVAC
ARMs
Experimental
Description
ALVAC-HIV Placebo at Weeks 0, 4 and 48; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
US Army Medical Research and Materiel Command; National Institute of Allergy and Infectious Diseases (NIAID)
September 2013
October 2018
Enrollment
360
20
Years
40
Years
Population
Women
Men
Sites

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok
Thailand

Royal Thai Army Clinical Research Center

Bangkok
Thailand

Research Institute for Health Sciences, Chiang Mai University

Chiang Mai
Thailand