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Placebo-Controlled Phase 3 Trial of a Recombinant Glycoprotein 120 Vaccine to Prevent HIV-1 Infection

Flynn, Neil M ; Forthal, Donald N ; Harro, Clayton D ; Judson, Franklyn N ; Mayer, Kenneth H ; Para, Michael F

The Journal of infectious diseases, 2005-03, Vol.191 (5), p.654-665 [Peer Reviewed Journal]

United States: The University of Chicago Press

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Title:
Placebo-Controlled Phase 3 Trial of a Recombinant Glycoprotein 120 Vaccine to Prevent HIV-1 Infection
Author: Flynn, Neil M ; Forthal, Donald N ; Harro, Clayton D ; Judson, Franklyn N ; Mayer, Kenneth H ; Para, Michael F
Subjects: Adolescent ; Adult ; AIDS ; AIDS vaccines ; AIDS Vaccines - immunology ; Disease Progression ; Female ; HIV 1 ; HIV Envelope Protein gp120 - immunology ; HIV Infections - prevention & control ; HIV-1 - immunology ; HIV/AIDS ; Human immunodeficiency virus 1 ; Human sexual behavior ; Humans ; Infections ; Injections ; Male ; Men ; Middle Aged ; Placebos ; Risk Factors ; Risk-Taking ; Time Factors ; Vaccination ; Vaccines, Synthetic - immunology ; Volunteerism
Is Part Of: The Journal of infectious diseases, 2005-03, Vol.191 (5), p.654-665
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Description: BackgroundA vaccine is needed to prevent human immunodeficiency virus type 1 (HIV-1) infection MethodsA double-blind, randomized trial of a recombinant HIV-1 envelope glycoprotein subunit (rgp120) vaccine was conducted among men who have sex with men and among women at high risk for heterosexual transmission of HIV-1. Volunteers received 7 injections of either vaccine or placebo (ratio, 2:1) over 30 months. The primary end point was HIV-1 seroconversion over 36 months ResultsA total of 5403 volunteers (5095 men and 308 women) were evaluated. The vaccine did not prevent HIV-1 acquisition: infection rates were 6.7% in 3598 vaccinees and 7.0% in 1805 placebo recipients; vaccine efficacy (VE) was estimated as 6% (95% confidence interval, −17% to 24%). There were no significant differences in viral loads, rates of antiretroviral-therapy initiation, or the genetic characteristics of the infecting HIV-1 strains between treatment arms. Exploratory subgroup analyses showed nonsignificant trends toward efficacy in preventing infection in the highest risk (VE, 43%; n=247) and nonwhite (VE, 47%; n=914) volunteers (P=.10, adjusted for multiple subgroup comparisons) ConclusionsThere was no overall protective effect. The efficacy trends in subgroups may provide clues for the development of effective immunization approaches
Publisher: United States: The University of Chicago Press
Language: English

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Placebo-Controlled Phase 3 Trial of a Recombinant Glycoprotein 120 Vaccine to Prevent HIV-1 Infection

Flynn, Neil M ; Forthal, Donald N ; Harro, Clayton D ; Judson, Franklyn N ; Mayer, Kenneth H ; Para, Michael F

United States: The University of Chicago Press

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