Safety and immunogenicity of hepatitis a vaccine in human immunodeficiency virus-infected patients: a double-blind, randomized, placebo-controlled trial

Kemper, C.A.; Haubrich, R.; Frank, I.; Dubin, G.; Buscarino, C.; McCutchan, J.A.; Deresinski, S.C.

Journal of Infectious Diseases 187(8): 1327-1331


ISSN/ISBN: 0022-1899
PMID: 12696015
DOI: 10.1086/374562
Accession: 011321770

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The safety and immunogenicity of inactivated hepatitis A (HepA) vaccine was assessed in 133 hepatitis A virus-seronegative, human immunodeficiency virus (HIV)-infected adults. Patients were randomly assigned to receive, in a blinded fashion, either 2 doses of vaccine (1440 enzyme-linked immunosorbent assay units) or placebo 6 months apart. Seroconversion at month 9 was observed in 68% of those with CD4 cell counts >/=200 cells/mm(3) but in only 9% of those with lower CD4 cell counts (P=.004). HepA vaccine was well tolerated and had no effect on the course of HIV infection or plasma HIV RNA load.