The aim was to determine whether the immunogenicity of an investigational
hepatitis B vaccine (spHB) is at least as high as that of a licensed control
vaccine,
Engerix B, and to evaluate its safety before inclusion in new pediatric
combination vaccines. Two randomized, controlled, blind-observer, Phase 3 trials were performed: one in Argentina (344 participants aged 10-15 years, 10 microg
HBsAg/dose) and one in Uruguay (344 participants aged 16-45 years, 20 microg
HBsAg/dose). Both
vaccines were given in a 0, 1, 6 month schedule to all participants with a baseline anti-Hep B antibody titer <0.6 mIU/mL. Antibody titers were measured pre-dose 1, 1 month after dose 2, pre-dose 3, and 1 month after dose 3. Statistical non-inferiority analyses were performed on seroprotection rates (SP) post-dose 3 (% with anti-Hep B titers >or=10 mIU/mL; delta non-inferiority limit of -10%). In both studies, SP for the spHB
vaccine was 100% and the spHB
vaccine was non-inferior in terms of SP to the licensed control
vaccine. GMTs post-dose 3 were approximately 1.8- and 4.1-fold higher for spHB in the 10-15 year and 16-45 year age groups, respectively. Reactogenicity was low for each
vaccine, after each dose. This highly immunogenic
hepatitis B candidate
vaccine was selected for further investigation as a component of new pediatric
combination vaccines.