Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose

Because HIV and hepatitis B virus share many common risk factors, it is important to try to vaccinate HIV patients against hepatitis B. There are numerous reports describing a variety of dose schedules, limited success and markers associated with impaired response to HBV vaccine in these individuals...

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Bibliographic Details
Published in:Vaccine 2005-04, Vol.23 (22), p.2902-2908
Main Authors: Fonseca, Marise Oliveira, Pang, Lorrin Wayie, Cavalheiro, Norma de Paula, Barone, Antônio Alci, Lopes, Marta Heloisa
Format: Article
Language:English
Subjects:
Adult
Antiretroviral drugs
Applied microbiology
Biological and medical sciences
CD4 T lymphocyte count
Dose-Response Relationship, Immunologic
Enzymes
Fundamental and applied biological sciences. Psychology
Hepatitis B - complications
Hepatitis B - prevention & control
Hepatitis B vaccine
Hepatitis B Vaccines - administration & dosage
HIV
HIV Infections - complications
HIV Infections - immunology
Human immunodeficiency virus
Human immunodeficiency virus (HIV)
Human viral diseases
Humans
Immunoassay
Infections
Infectious diseases
Laboratories
Logistics
Medical sciences
Microbiology
Miscellaneous
Studies
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Viral hepatitis
Virology
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Summary:Because HIV and hepatitis B virus share many common risk factors, it is important to try to vaccinate HIV patients against hepatitis B. There are numerous reports describing a variety of dose schedules, limited success and markers associated with impaired response to HBV vaccine in these individuals. All studies have been small in size making it difficult to draw conclusions within and between studies. The purpose of this study was to evaluate a double dose of hepatitis B vaccine under more definitive guidelines: double blinded, randomized, controlled, with numbers for statistical validity. Two hundred and ten HIV infected subjects received a standard dose (20 μg) or a double dose (40 μg) of recombinant hepatitis B vaccine IM 0, 1 and 6 months. Ninety-four receiving standard dose and 98 receiving double dose completed the study. The seroconversion rate (anti-HBs ≥ 10 mIU/mL) was 47 and 34% for double dose and standard dose, respectively ( p = 0.07). A statistically significant higher seroconversion rate was associated with double dose comparing with standard dose for patients with CD4 cell counts ≥350 cells/mm 3 (64.3% × 39.3%; p = 0.008) but made no difference to seroconversion in those with CD4
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2004.11.057