Safety and immunogenicity of an inactivated hepatitis A vaccine among HIV-infected subjects.
BACKGROUND
Hepatitis A is a major health risk for many human immunodeficiency virus (HIV)-infected individuals. Vaccination is a potentially attractive measure to reduce the incidence of hepatitis A among this population, but data on its safety and immunogenicity are incomplete.


METHODS
Ninety HIV-uninfected adults received an inactivated hepatitis A vaccine (VAQTA; Merck), and 90 HIV-infected subjects were randomized, in double-blind fashion, to receive either the vaccine or placebo. The HIV-infected subjects were stratified by CD4 cell count, with 45 subjects having CD4 cell counts of > or =300 cells/mm3 and 45 subjects having CD4 cell counts of <300 cells/mm3. Vaccine was given at weeks 0 and 24 of the study.Results. Seroconversion rates at week 28 of the study were 94% among the HIV-infected subjects and 100% among the HIV-uninfected control subjects. HIV-infected subjects with CD4 cell counts of <300 cells/mm3 had a seroconversion rate of 87%, and HIV-infected subjects with CD4 cell counts of > or =300 cells/mm3 had a seroconversion rate of 100%. The vaccine was generally well tolerated, and no adverse effect on either HIV load or CD4 cell count was found.


CONCLUSIONS
Hepatitis A vaccine was both immunogenic and safe among HIV-infected subjects.
Wallace
Mark R
MR
Clinical Investigation Dept., Naval Medical Center San Diego, San Diego, California 92134-1005, USA. MRWallace@nmcsd.med.navy.mil
Brandt
Carolyn J
CJ
Earhart
Kenneth C
KC
Kuter
Barbara J
BJ
Grosso
Anthony D
AD
Lakkis
Hassan
H
Tasker
Sybil A
SA
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; 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*; D006801:Humans; D008297:Male; D015164:Vaccines, Inactivated / Q000009:adverse effects* / Q000276:immunology*; D019562:Viral Load
D000914:Antibodies, Viral; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated