Safety and immunogenicity of hepatitis A vaccine in human immunodeficiency virus-infected patients: a double-blind, randomized, placebo-controlled trial.
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.
Kemper
Carol A
CA
Division of Infectious Diseases, Department of Medicine, Santa Clara Valley Medical Center, San Jose, California, USA. cakemper@earthlink.net
Haubrich
Richard
R
Frank
Ian
I
Dubin
Gary
G
Buscarino
Charles
C
McCutchan
J Allen
JA
Deresinski
Stanley C
SC
D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D015658:HIV Infections / Q000150:complications / Q000276:immunology*; D006506:Hepatitis A / Q000150:complications / Q000276:immunology* / Q000517:prevention & control*; D022362:Hepatitis A Vaccines / Q000009:adverse effects* / Q000276:immunology*; D030041:Hepatitis A virus / Q000276:immunology; D006801:Humans; D013997:Time Factors; D019562:Viral Load
D022362:Hepatitis A Vaccines