IMMUNOGENICITY AND SAFETY OF A NEW INACTIVATED HEPATITIS-A VACCINE - A CLINICAL-TRIAL WITH COMPARISON OF ADMINISTRATION ROUTE

A bicentre, controlled randomized open trial was carried out in order to compare the immunogenicity and the reactogenicity of PASTEUR MERIEU X Serums et Vaccins inactivated Hepatitis A Vaccine on adults, when us ed with different routes of administration [intramuscular (i.m.), subc utaneous (s.c.) and needless injection using a Jet injector device]. V accines were given at two doses 6 months apart to 147 seronegative sub jects, Anti-Hepatitis A virus (HAV) titres were performed at each visi t by modified radioimmunoassay assay. After the first dose, 138 subjec ts except one seroconverted (s.c.). After booster nose, all subjects e xhibited high levels of HAV antibodies. The higher titres were observe d with Jet injector (GMT: 305 mIU ml(-1) after the first dose and 3727 mIU ml(-1) after the booster dose;), followed by the i.m. route (210 mIU ml(-1), 3152 mIU ml(-1)) and the s.c. route (165 mIU ml(-1), 2082 mIU ml(-1)). No statistically significant differences were observed in the three paired comparisons (i.m. vs jet injector; jet vs s.c., im v s s.c.). This inactivated hepatitis A vaccine appeared to be highly im munogenic after one single dose and one booster 6 months later. Copyri ght (C) 1996 Elsevier Science Ltd.