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Clinical Trial
. 2003 Apr 15;187(8):1327-31.
doi: 10.1086/374562. Epub 2003 Mar 24.

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

Carol A Kemper  1 , Richard Haubrich, Ian Frank, Gary Dubin, Charles Buscarino, J Allen McCutchan, Stanley C Deresinski; California Collaborative Treatment Group
Affiliations
Clinical Trial

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

Carol A Kemper et al. J Infect Dis. .

Abstract

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.

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