title: Long-term follow-up: no effect of therapeutic vaccination with HIV-1 p17/p24:Ty virus-like particles on HIV-1 disease progression.
abstract: Long-term effects of therapeutic vaccination of human immunodeficiency virus (HIV)-1-infected subjects with HIV-1 p17/p24:Ty virus-like particles (p24-VLP) on progression to AIDS, death, a CD4 cell count <or=200 cells/mm(3) and CD4 cell count decline were studied in a multicenter cohort study of 56 individuals who participated in a phase II double-blind placebo-controlled trial with p24-VLP in 1993. Using Cox proportional hazard analysis, no difference between vaccine and placebo groups was found in progression to death (adjusted hazard rate (HR): 0.68 (95% CI: 0.05-7.83), AIDS (adjusted HR: 1.07 (95% CI: 0.21-5.36)) and a CD4 cell count <or=200 cells/mm(3) (adjusted HR: 1.00 (95% CI: 0.35-2.87)). Using linear regression with correction for multiple visits within one person, no effect of vaccination on CD4 cell count decline, adjusted for antiretroviral therapy (ART) use, was found (P=0.98). In conclusion, therapeutic vaccination with p24-VLP is not related to slower HIV-1 disease progression.
authors: The Municipal Health Service of Amsterdam, Cluster Infectious Diseases, Amsterdam, The Netherlands. klindenburg@gggd.amsterdam.nl
authors: Catharina E A
authors: CE
authors: Lindenburg
authors: Ineke
authors: I
authors: Stolte
authors: Miranda W
authors: MW
authors: Langendam
authors: Frank
authors: F
authors: Miedema
authors: Ian G
authors: IG
authors: Williams
authors: Robert
authors: R
authors: Colebunders
authors: Jonathan N
authors: JN
authors: Weber
authors: Martin
authors: M
authors: Fisher
authors: Roel A
authors: RA
authors: Coutinho
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology / Q000627:therapeutic use*; D000368:Aged; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015683:Gene Products, gag / Q000276:immunology / Q000627:therapeutic use*; D015488:HIV Antigens / Q000276:immunology / Q000627:therapeutic use*; D016655:HIV Core Protein p24 / Q000276:immunology / Q000627:therapeutic use*; D015658:HIV Infections / Q000276:immunology* / Q000503:physiopathology / Q000628:therapy*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014611:Vaccination; D014764:Viral Proteins; D054301:gag Gene Products, Human Immunodeficiency Virus
chemical_list: D016915:AIDS Vaccines; D015683:Gene Products, gag; D015488:HIV Antigens; D016655:HIV Core Protein p24; D014764:Viral Proteins; D054301:gag Gene Products, Human Immunodeficiency Virus; C054858:p17 protein, Human Immunodeficiency Virus Type 1; C065031:p24-VLP vaccine