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


CONCLUSIONS
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).


BACKGROUND
CT00230061.
Department of Internal Medicine-Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands. t.sluijs@erasmusmc.nl
Theodora E M S
TE
de Vries-Sluijs
Bettina E
BE
Hansen
Gerard J J
GJ
van Doornum
Robert H
RH
Kauffmann
Eliane M S
EM
Leyten
Tania
T
Mudrikova
Kees
K
Brinkman
Jan G
JG
den Hollander
Frank P
FP
Kroon
Harry L A
HL
Janssen
Marchina E
ME
van der Ende
Robert A
RA
de Man
D000328:Adult; D000368:Aged; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000379:methods*; D016903:Drug Monitoring
D017325:Hepatitis B Vaccines