Abstract
To determine the long-term safety of inactivated hepatitis A virus (HAV) vaccine in men infected with HIV-1. A 1-year prospective case-control study. Targeted primary care and sexually transmitted diseases clinics. Ninety HIV-1-positive patients who participated in an earlier efficacy study of HAV vaccination. Ninety HIV-1-positive men, matched for CD4+ lymphocyte percentage at baseline, who did not receive HAV vaccine. All cases were assigned to receive two intramuscular doses of 1440 enzyme-linked immunosorbent assay units of inactivated HAV vaccine (Havrix) either 1 or 6 months apart. Development of AIDS, survival, and T-cell subsets after 1 year of follow-up. No significant differences were seen between cases and control for the development of AIDS (10.1 versus 10.7%), deaths (7.3 versus 7.6%) nor for mean decline in circulating CD4+ lymphocyte count (125 versus 123 x 10(6)/1) after 1 year. Vaccination against HAV appears to be safe in the longer term for HIV-1-infected men.
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