Abstract
Sixty healthy nonresponders were randomized to receive intramuscular (IM) high dose hepatitis B virus (HBV) vaccine versus IM standard dose HBV vaccine plus granulocyte-macrophage colony-stimulating factor (GM-CSF) at 0-2 months. Antibody to hepatitis B surface antigen was measured 1 month after each dose and 3 months after the last dose. Two regimens were equivalent in eliciting seroprotection in nonresponders. Weight-height index (WHI) <39 and alanine transaminase (ALT) <39 mg/dl predicted which nonresponders would seroconvert. A three-dose regimen of standard dose HBV vaccine plus GM-CSF may be a useful for seroprotection of healthy nonresponders.
Copyright 2002 Elsevier Science Ltd.
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic*
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Adolescent
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Adult
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Aged
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Dose-Response Relationship, Immunologic
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Female
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Follow-Up Studies
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Granulocyte-Macrophage Colony-Stimulating Factor / immunology*
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Hepatitis B Antibodies / biosynthesis*
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Hepatitis B Vaccines / administration & dosage
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Hepatitis B Vaccines / immunology*
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Humans
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Immunization, Secondary*
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Injections, Intramuscular
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Male
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Middle Aged
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Vaccines, Synthetic / administration & dosage
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Vaccines, Synthetic / immunology*
Substances
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Adjuvants, Immunologic
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Hepatitis B Antibodies
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Hepatitis B Vaccines
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Recombivax HB
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Vaccines, Synthetic
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Granulocyte-Macrophage Colony-Stimulating Factor