Immunogenicity and safety of a virosomal hepatitis A vaccine in HIV-positive patients

Abstract

This short report presents results of an open uncontrolled single centre study which evaluated immunogenicity and safety of a virosome-formulated hepatitis A vaccine (Epaxal) in 14 HIV-positive adult patients and 64 healthy adults receiving a primary immunisation and a booster dose 12 months later. Seroconversion rates (> or =20 mIU/mL), geometric mean concentration (GMC) of anti-HAV antibodies, local and systemic adverse events (AEs) were assessed at baseline and at Months 1, 6, 12, and 13. The seroconversion rate was 63.6% at Month 1 and 91.7% at Month 13 in HIV-positive patients versus 93.8 and 100% in healthy adults. The booster dose increased GMCs from 25.5 to 659.2 mIU/mL in HIV-positive patients versus 104 and 2986 mIU/mL in healthy adults. Epaxal was well tolerated by the HIV-positive patients and was at least as immunogenic as reported for aluminium-adsorbed vaccines. In conclusion, Epaxal can be considered an immunogenic and safe hepatitis A vaccine in HIV-positive patients.