Supachai Rerks-NgarmRobert M. ParisSupamit ChunsutthiwatNakorn PremsriChawetsan NamwatChureeratana BowonwatanuwongShuying S. LiJaranit KaewkungkalRapee TrichavarojNampueng ChurikanontMark S. De SouzaCharla AndrewsDonald FrancisElizabeth AdamsJorge FloresSanjay GurunathanJim TartagliaRobert J. O'ConnellChirapa EamsilaSorachai NitayaphanViseth NgauyPrasert ThongcharoenPrayura KunasolNelson L. MichaelMerlin L. RobbPeter B. GilbertJerome H. KimThailand Ministry of Public HealthUS Military HIV Research ProgramChonburi Regional HospitalFred Hutchinson Cancer Research CenterMahidol UniversityArmed Forces Research Institute of Medical Sciences, ThailandGlobal Solutions in Infectious DiseasesNational Institute of Allergy and Infectious DiseasesSanofi PasteurRoyal Thai Army2018-10-192018-10-192013-04-15Journal of Infectious Diseases. Vol.207, No.8 (2013), 1195-1205002218992-s2.0-84875579579https://repository.li.mahidol.ac.th/handle/20.500.14594/32391Background. 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.Mahidol UniversityMedicineArticleSCOPUS10.1093/infdis/jis478