IMMUNOGENICITY AND ADVERSE-EFFECTS OF INACTIVATED VIROSOME VERSUS ALUM-ADSORBED HEPATITIS-A VACCINE - A RANDOMIZED CONTROLLED TRIAL

Immunogenicity and adverse effects of a novel inactivated hepatitis A vaccine based on virosomes (IRIV-HAV) was compared with a standard vac cine adsorbed to aluminium (Al-HAV). Seronegative volunteers (n=301) w ere randomly allocated to one injection of IRIV-HAV or to two injectio ns of Al-HAV, followed by a booster injection at 12 months. Two hundre d and ninety-eight (99%) completed the first month and 215 (71%) could be evaluated at 1 year. Geometric mean antibody concentrations at day s 0, 14 and at 12 months were similar in the two vaccine groups. Lower antibody concentrations were recorded with IRIV-HAV at day 28 (P<0.00 01) and at 13 months (P=0.02). Seroconversion to protective antibody l evels, however, was similar (98% at day 28, 94% at 12 months, 100% at 13 months). Local adverse effects were reported in 17% with IRIV-HAV b ut in 66% with Al-HAV (P<0.0001) after the initial vaccination and in 32% and 42% following the booster vaccination (P=0.05). lit conclusion , IRIV-HAV may provide similar protection but cause less local adverse effects. Copyright (C) 1996 Elsevier Science Ltd.