Publication: Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand
2
Issued Date
2006-12-15
Resource Type
ISSN
00221899
DOI
Other identifier(s)
2-s2.0-33845433434
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Infectious Diseases. Vol.194, No.12 (2006), 1661-1671
Suggested Citation
Punnee Pitisuttithum, Peter Gilbert, Marc Gurwith, William Heyward, Michael Martin, Fritz Van Griensven, Dale Hu, Jordan W. Tappero, Kachit Choopanya Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. Journal of Infectious Diseases. Vol.194, No.12 (2006), 1661-1671. doi:10.1086/508748 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/23402
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand
Abstract
Background. In Thailand, phase 1/2 trials of monovalent subtype B and bivalent subtype B/E (CRF01_AE) recombinant glycoprotein 120 human immunodeficiency virus type 1 (HIV-1) vaccines were successfully conducted from 1995 to 1998, prompting the first HIV-1 vaccine efficacy trial in Asia. Methods. This randomized, double-blind, placebo-controlled efficacy trial of AIDSVAX B/E (VaxGen), which included 36-months of follow-up, was conducted among injection drug users (IDUs) in Bangkok, Thailand. The primary end point was HIV-1 infection; secondary end points included plasma HIV-1 load, CD4 cell count, onset of acquired immunodeficiency syndrome-defining conditions, and initiation of antiretroviral therapy. Results. A total of 2546 IDUs were enrolled between March 1999 and August 2000; the median age was 26 years, and 93.4% were men. The overall HIV-1 incidence was 3.4 infections/100 person-years (95% confidence interval [CI], 3.0-3.9 infections/100 person-years), and the cumulative incidence was 8.4%. There were no differences between the vaccine and placebo arms. HIV-1 subtype E (83 vaccine and 81 placebo recipients) accounted for 77% of infections. Vaccine efficacy was estimated at 0.1% (95% CI, -30.8% to 23.8%; P = .99, log-rank test). No statistically significant effects of the vaccine on secondary end points were observed. Conclusion. Despite the successful completion of this efficacy trial, the vaccine did not prevent HIV-1 infection or delay HIV-1 disease progression. © 2006 by the Infectious Diseases Society of America. All rights reserved.