Immunogenicity and safety of a novel yeast Hansenula polymorpha-derived recombinant Hepatitis B candidate vaccine in healthy adolescents and adults aged 10-45 years.
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| 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.
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| Authors | Miguel W Tregnaghi, Ricardo Voelker, Eduardo Santos-Lima, Betzana Zambrano |
| Journal | Vaccine (Vaccine) Vol. 28 Issue 20 Pg. 3595-601 (Apr 30 2010) ISSN: 1873-2518 [Electronic] Netherlands |
| PMID | 20189492 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial) |
| Copyright | (c) 2010. Published by Elsevier Ltd. |
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