Publication: AIDSVAX® (MN) in Bangkok injecting drag users: A report on safety and immunogenicity, including macrophage-tropic virus neutralization
Issued Date
2000-05-01
Resource Type
ISSN
08892229
Other identifier(s)
2-s2.0-0034178248
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Mahidol University
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SCOPUS
Bibliographic Citation
AIDS Research and Human Retroviruses. Vol.16, No.7 (2000), 655-663
Suggested Citation
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 AIDSVAX® (MN) in Bangkok injecting drag users: A report on safety and immunogenicity, including macrophage-tropic virus neutralization. AIDS Research and Human Retroviruses. Vol.16, No.7 (2000), 655-663. doi:10.1089/088922200308882 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/25986
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Title
AIDSVAX® (MN) in Bangkok injecting drag users: A report on safety and immunogenicity, including macrophage-tropic virus neutralization
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.