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.
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.
authors: Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.
authors: Supachai
authors: S
authors: Rerks-Ngarm
authors: Robert M
authors: RM
authors: Paris
authors: Supamit
authors: S
authors: Chunsutthiwat
authors: Nakorn
authors: N
authors: Premsri
authors: Chawetsan
authors: C
authors: Namwat
authors: Chureeratana
authors: C
authors: Bowonwatanuwong
authors: Shuying S
authors: SS
authors: Li
authors: Jaranit
authors: J
authors: Kaewkungkal
authors: Rapee
authors: R
authors: Trichavaroj
authors: Nampueng
authors: N
authors: Churikanont
authors: Mark S
authors: MS
authors: de Souza
authors: Charla
authors: C
authors: Andrews
authors: Donald
authors: D
authors: Francis
authors: Elizabeth
authors: E
authors: Adams
authors: Jorge
authors: J
authors: Flores
authors: Sanjay
authors: S
authors: Gurunathan
authors: Jim
authors: J
authors: Tartaglia
authors: Robert J
authors: RJ
authors: O'Connell
authors: Chirapa
authors: C
authors: Eamsila
authors: Sorachai
authors: S
authors: Nitayaphan
authors: Viseth
authors: V
authors: Ngauy
authors: Prasert
authors: P
authors: Thongcharoen
authors: Prayura
authors: P
authors: Kunasol
authors: Nelson L
authors: NL
authors: Michael
authors: Merlin L
authors: ML
authors: Robb
authors: Peter B
authors: PB
authors: Gilbert
authors: Jerome H
authors: JH
authors: Kim
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000276:immunology / Q000473:pathology / Q000517:prevention & control / Q000821:virology*; D015497:HIV-1 / Q000276:immunology* / Q000472:pathogenicity; D006801:Humans; D016014:Linear Models; D008297:Male; D011446:Prospective Studies; D012309:Risk-Taking; D012661:Semen / Q000821:virology; D013785:Thailand; D013997:Time Factors; D014611:Vaccination; D014621:Vagina / Q000821:virology; D019562:Viral Load; D014765:Viral Vaccines / Q000008:administration & dosage / Q000276:immunology*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines; C574872:AIDSVAX B-E; C078788:ALVAC vaccine; D014765:Viral Vaccines