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Title: Extended evaluation of the virologic, immunologic, and clinical course of volunteers who acquired HIV-1 infection in a phase III vaccine trial of ALVAC-HIV and AIDSVAX B/E
Authors: Supachai Rerks-Ngarm
Robert M. Paris
Supamit Chunsutthiwat
Nakorn Premsri
Chawetsan Namwat
Chureeratana Bowonwatanuwong
Shuying S. Li
Jaranit Kaewkungkal
Rapee Trichavaroj
Nampueng Churikanont
Mark S. De Souza
Charla Andrews
Donald Francis
Elizabeth Adams
Jorge Flores
Sanjay Gurunathan
Jim Tartaglia
Robert J. O'Connell
Chirapa Eamsila
Sorachai Nitayaphan
Viseth Ngauy
Prasert Thongcharoen
Prayura Kunasol
Nelson L. Michael
Merlin L. Robb
Peter B. Gilbert
Jerome H. Kim
Thailand Ministry of Public Health
US Military HIV Research Program
Chonburi Regional Hospital
Fred Hutchinson Cancer Research Center
Mahidol University
Armed Forces Research Institute of Medical Sciences, Thailand
Global Solutions in Infectious Diseases
National Institute of Allergy and Infectious Diseases
Sanofi Pasteur
Royal Thai Army
Keywords: Medicine
Issue Date: 15-Apr-2013
Citation: Journal of Infectious Diseases. Vol.207, No.8 (2013), 1195-1205
Abstract: Background. The Thai Phase III Trial of ALVAC-HIV and AIDSVAX B/E showed an estimated vaccine efficacy (VE) of 31% to prevent acquisition of human immunodeficiency virus (HIV). Here we evaluated the effect of vaccination on disease progression after infection.Methods. CD4+T-cell counts and HIV viral load (VL) were measured serially. The primary analysis evaluated vaccine efficacy (VEP) as the percent reduction (vaccine vs placebo) in cumulative probability of a primary composite endpoint of clinical and CD4+count components at prespecified time points after infection. Secondary analyses of biomarker-based endpoints were assessed using marginal mean and linear mixed models.Results. There were 61 endpoints in the modified intent-to-treat cohort (mITT; n = 114). There was no evidence for efficacy at 30, 42, 54, and 60 months in the mITT and per protocol (n = 90) cohorts. Estimated VEP(mITT) was15.8% (-21.9, 41.8) at 60 months postinfection. There was weak evidence of lower VL and higher CD4+count at 60 and 66 months in the vaccine group. Lower mucosal VL was observed among vaccine recipients, primarily in semen (P =. 04).Conclusions. Vaccination did not affect the clinical course of HIV disease after infection. A potential vaccine effect on the genital mucosa warrants further study.Trial registration. identifier: NCT00337181. © 2012 Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
ISSN: 00221899
Appears in Collections:Scopus 2011-2015

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