Publication:
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

Issued Date

2013-04-15

Resource Type

Article

ISSN

00221899

DOI

10.1093/infdis/jis478

Other identifier(s)

2-s2.0-84875579579

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Journal of Infectious Diseases. Vol.207, No.8 (2013), 1195-1205

Suggested Citation

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 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. Journal of Infectious Diseases. Vol.207, No.8 (2013), 1195-1205. doi:10.1093/infdis/jis478 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/32391

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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

Author(s)

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

Other Contributor(s)

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

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. © 2012 Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/32391

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