Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand

被引:635
|
作者
Pitisuttithum, Punnee
Gilbert, Peter
Gurwith, Marc
Heyward, William
Martin, Michael
van Griensven, Fritz
Hu, Dale
Tappero, Jordan W.
Choopanya, Kachit
机构
[1] Mahidol Univ, Fac Trop Med, Dept Clin Trop Med, Clin Infect Dis Res Unit, Bangkok 10400, Thailand
[2] Bangkok Metropolitan Adm, Bangkok, Thailand
[3] US Ctr Dis Control & Prevent Collaborat, Thailand Minist Publ Hlth, Nonthaburi, Thailand
[4] Fred Hutchinson Canc Res Ctr, Stat Ctr HIV AIDS Res & Prevent, Seattle, WA 98104 USA
[5] VaxGen Inc, Brisbane, CA USA
[6] US Ctr Dis Control & Prevent, Atlanta, GA USA
来源
JOURNAL OF INFECTIOUS DISEASES | 2006年 / 194卷 / 12期
关键词
D O I
10.1086/508748
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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%;, log-rank test). Pp. 99 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.
引用
收藏
页码:1661 / 1671
页数:11
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