title: Immunogenicity and safety of a novel yeast Hansenula polymorpha-derived recombinant Hepatitis B candidate vaccine in healthy adolescents and adults aged 10-45 years.
abstract: 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.
authors.affiliation: Centro de Desarrollo de Proyectos Avanzados, Roma 1465, 5000 Córdoba, Argentina. miguelt@millicom.com.ar
authors.forename: Miguel W
authors.initials: MW
authors.lastname: Tregnaghi
authors.forename: Ricardo
authors.initials: R
authors.lastname: Voelker
authors.forename: Eduardo
authors.initials: E
authors.lastname: Santos-Lima
authors.forename: Betzana
authors.initials: B
authors.lastname: Zambrano
mesh_terms: D000293:Adolescent; D000328:Adult; D001118:Argentina; D002648:Child; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010843:Pichia / Q000276:immunology*; D016037:Single-Blind Method; D014583:Uruguay; D055815:Young Adult
chemical_list: C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines