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

AUTHOR(S)
Rerks-Ngarm, Supachai; Paris, Robert M.; Chunsutthiwat, Supamit; Premsri, Nakorn; Namwat, Chawetsan; Bowonwatanuwong, Chureeratana; Li, Shuying S.; Kaewkungkal, Jaranit; Trichavaroj, Rapee; Churikanont, Nampueng; de Souza, Mark S.; Andrews, Charla; Francis, Donald; Adams, Elizabeth; Flores, Jorge; Gurunathan, Sanjay; Tartaglia, Jim; O'Connell, Robert J.; Eamsila, Chirapa; Nitayaphan, Sorachai
PUB. DATE
April 2013
SOURCE
Journal of Infectious Diseases;Apr2013, Vol. 207 Issue 8, p1195
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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. Clinicaltrials.gov identifier: NCT00337181.
ACCESSION #
86428996

 

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