A randomized controlled study of accelerated versus standard hepatitis B vaccination in HIV-positive patients.

Author(s): de Vries-Sluijs TE, Hansen BE, van Doornum GJ, Kauffmann RH, Leyten EM, Mudrikova T, Brinkman K, den Hollander JG, Kroon FP, Janssen HL, van der Ende ME, de Man RA

Affiliation(s): Department of Internal Medicine-Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands. t.sluijs@erasmusmc.nl

Publication date & source: 2011-04-01, J Infect Dis., 203(7):984-91. Epub 2011 Jan 25.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: In human immunodeficiency virus (HIV)-infected patients, the immunogenicity of hepatitis B vaccines is impaired. The primary and secondary aims of our study were to investigate the effectiveness and compliance of 2 different vaccination regimen in an HIV-infected population. METHODS: A noninferiority trial with a 10% response margin was designed. Included were patients >/= 18 years old, with negative HBsAg/anti-HBc serology, and not previously vaccinated against hepatitis B. Patients were stratified according to CD4(+) cell count: <200, 200-500, >500. Participants received 10 mug HBvaxPRO intramuscularly according to a 0-1-3 week schedule or the standard 0-4-24 week schedule. Anti-HBs levels were measured at week 28, considered protective >/= 10 IU/L. RESULTS: Modified intention to treat analysis in 761 patients was performed. Overall response difference was 50%(standard arm) versus 38.7% (accelerated arm) =11.3% (95% confidence interval [CI], [4.3, 18.3]), close to the 10% response margin. In CD4(+) cell count group 200-500 cells/mm(3,) the response difference was 20.8% (95% CI [10.9, 30.7]). However, the response difference in CD4(+)cell count group >500 cells/mm(3) was -1.8% (95% CI [-13.4,+9.7]). Compliance was significantly superior with the accelerated schedule, 91.8% versus 82.7% (P </= .001). CONCLUSION: In HIV-infected patients, compliance with an accelerated hepatitis B vaccination schedule is significantly better. The efficacy of an accelerated schedule proved to be non-inferior in CD4(+) cell count group >500 cells/mm(3). CLINICAL TRIALS REGISTRATION: CT00230061.