View All Abstracts for Session 45
241 Long-Term Follow-Up: No Effect of Therapeutic Vaccination with HIV-1 P17/P24:Ty Virus-Like Particles on HIV-1 Disease Progression
C. Lindenburg1, I. Stolte1, M. Langendam1, F. Miedema2,3, and R. Coutinho*1,3, on behalf of the participating centers
1Municipal Hlth. Service of Amsterdam, The Netherlands; 2CLB/Sanquin, Amsterdam, The Netherlands; and 3Academic Med. Ctr., Amsterdam, The Netherlands
Background: Therapeutic vaccination could be a valuable addition to HIV treatment. We evaluated the long-term effects of a phase II double-blind placebo-controlled multi-center therapeutic vaccination trial with HIV-1 P17/P24:Ty virus-like particles (p24-VLP, British Biotech).
Methods: A multicenter cohort study among 74 participants of the 1993/1994 phase II therapeutic vaccination trial with p24-VLP. Inclusion criteria: (1) asymptomatic HIV-1 infection, (2) CD4 cell count >350 cells/mm3, and (3) no current intravenous drug use. Since previous studies found that only high doses of p24-VLP induce an immune response, subjects from the 100-mug group were excluded (n = 18). The effect of vaccination on progression to AIDS, death, and a CD4 cell count (200 cells/mm3 was studied using Cox proportional hazard analysis. The CD4 cell decline was compared between the vaccinated and nonvaccinated group using linear regression with correction for multiple visits within one person.
Results: Fifty males and 6 females, mean age at study entry 37 (SD = 9), entered the study. At baseline the 19 placebo recipients and 37 subjects receiving either 500 or 1,000 mug of p24-VLP were comparable in ethnic background, sex, age, CD4 cell count, and use of antiretroviral therapy (ART). The groups did not differ in follow-up time and use of ART during the study period. Thirty subjects received HAART during follow-up. Mean follow-up was 56 months (SD 19). During 261 person years of follow-up, 3 subjects died, 10 progressed to AIDS (1993 Expanded European AIDS case definition), and 20 reached the endpoint of a CD4 cell count (200 cells/mm3. The adjusted HR of vaccination with p24-VLP for progression to AIDS was 1.07 (95% CI: 0.21-5.36). For progression to a CD4 cell count (200 cells/mm3 the adjusted HR was 1.00 (95% CI: 0.35-2.87). There was no effect of vaccination on the CD4 cell decline adjusted for (HA)ART use (p = 0.98).
Conclusions: We found no effect of therapeutic vaccination with p24-VLP on HIV-1 disease progression.
Contact Author about this Abstract
