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Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04

2004; Elsevier BV; Volume: 23; Issue: 3 Linguagem: Inglês

10.1016/j.vaccine.2004.06.006

1873-2518

Greet J. Boland, Jiřı́ Beran, Marc Lievens, Jose Sasadeusz, P Dentico, Hans Dieter Nothdurft, JN Zuckerman, Blaise Genton, Robert Steffen, Louis Loutan, Jan van Hattum, M. Stoffel,

Immunotherapy and Immune Responses

The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers ≥15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.