Long-term follow-up: no effect of therapeutic vaccination with HIV-1 p17/p24:Ty virus-like particles on HIV-1 disease progression

• Published in: Vaccine 2002-05, Vol.20 (17), p.2343-2347
• Main Authors: Lindenburg, Catharina E.A., Stolte, Ineke, Langendam, Miranda W., Miedema, Frank, Williams, Ian G., Colebunders, Robert, Weber, Jonathan N., Fisher, Martin, Coutinho, Roel A.
• Format: Article
• Language: English
• Subjects: Aged; AIDS Vaccines - immunology; AIDS Vaccines - therapeutic use; Biological and medical sciences; CD4 Lymphocyte Count; Disease Progression; Double-Blind Method; Female; Follow-Up Studies; gag Gene Products, Human Immunodeficiency Virus; Gene Products, gag - immunology; Gene Products, gag - therapeutic use; HIV Antigens - immunology; HIV Antigens - therapeutic use; HIV Core Protein p24 - immunology; HIV Core Protein p24 - therapeutic use; HIV Infections - immunology; HIV Infections - physiopathology; HIV Infections - therapy; HIV-1 - immunology; HIV-1 p17/p24:Ty virus-like particles; Human viral diseases; Humans; Infectious diseases; Long-term effects; Male; Medical sciences; Middle Aged; Therapeutic vaccination; Time Factors; Vaccination; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Proteins
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(02)00102-0

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 ≤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 ≤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.