Immunogenicity and reactogenicity of a combined hepatitis A/B candidate vaccine: first results.

Abstract

We evaluated immunogenicity and reactogenicity of an inactivated, combined hepatitis A/B candidate vaccine in 50 seronegative volunteers. Each volunteer received a total of three doses of vaccine (720 EIU HAV and 20 micrograms HBs antigen) according to a 0, 1 and 6 month vaccination schedule. One month after the first injection, the seroconversion rate was 90% (45/50) for anti-HAV and 28% (14/50) for anti-HBs, respectively. After the booster dose, at month 7, the seroconversion rate was as high as 100% (49/49) for anti-HAV and 94% (46/49) for anti-HBs. The geometric mean titres increased with each dose of vaccine administered. Mild, and mostly local side effects were reported in 54% of the volunteers after the first injection and in less than 10% after the third injection. Our results show that this inactivated, candidate hepatitis A/B vaccine is highly immunogenic and well-tolerated.