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Title: AIDSVAX® (MN) in Bangkok injecting drag users: A report on safety and immunogenicity, including macrophage-tropic virus neutralization
Authors: Sricharoen Migasena
Pravan Suntharasamai
Punnee Pitisuttithum
Dwip Kitayaporn
Chantapong Wasi
Wei Huang
Suphak Vanichseni
Charnchai Koompong
Jaranit Kaewkungwal
Suwanee Raktham
Tina Ippolito
Carl Hanson
Timothy Gregory
William L. Heyward
Phillip Berman
Donald P. Francis
Mahidol University
Genentech Incorporated
Bangkok Metropolitan Administration
VaxGen, Inc.
California Department of Health Services
Organisation Mondiale de la Sante
Centers for Disease Control and Prevention
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-May-2000
Citation: AIDS Research and Human Retroviruses. Vol.16, No.7 (2000), 655-663
Abstract: A randomized, double-blind, placebo-controlled phase I/II study of AIDSVAX® (MN) was conducted among injecting drug users in Bangkok, Thailand. Four doses of vaccine (300 μg of MN-rgp120 in alum) or placebo (alum) were given at study entry and at 1, 6, and 12 months. The objectives of the study were to evaluate (1) the feasibility of conducting vaccine trials in this population; (2) the safety of this candidate AIDS vaccine; and (3) the immunogenicity of this vaccine. Thirty-three volunteers (22 vaccine and 11 placebo recipients) were recruited. None were lost to follow-up during the 18-month study. Mild reactogenicity was noted, which was similar in both vaccine and placebo recipients. The vaccine induced anti-HIV-1 antibody in all vaccine recipients. Maximal titers of binding antibodies of MN-rgp120 and the V3 domain of MN-rgp120 were induced after the third (6 month) dose while maximal neutralizing antibodies followed the fourth (12 month) dose. The vaccine-induced antibodies from several volunteers were capable of neutralizing macrophage-tropic, subtype B viruses (301660 and JRCSF) detected in a PBMC-based assay. Binding and neutralizing antibodies declined about 10- fold in the 6 months after the last boost. Two vaccinees became infected during the trial, both with subtype E viruses. A phase III efficacy trial, using a bivalent gp120, vaccine containing antigens from a subtype B virus (MN) and a subtype E virus (A244), was initiated in March 1999 in injecting drug users in Bangkok.
ISSN: 08892229
Appears in Collections:Scopus 1991-2000

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