The effect of immunization with inactivated hepatitis A vaccine on the clinical course of HIV-1 infection: 1-year follow-up

Objective: To determine the long-term safety of inactivated hepatitis A virus (HAV) vaccine in men infected with HIV-1. Design: A 1-year prospective case-control study. Setting: Targeted primary care and sexually transmitted diseases clinics. Patients: Ninety HIV-1-positive patients who participated in an earlier efficacy study of HAV vaccination. Controls: Ninety HIV-1-positive men, matched for CD4+ lymphocyte percentage at baseline, who did not receive HAV vaccine. Intervention: 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. Main outcome measures: Development of AIDS, survival, and T-cell subsets after 1 year of follow-up. Results: 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 123x10(6)/l) after 1 year. Conclusions: Vaccination against HAV appears to be safe in the longer term for HIV-1-infected men.