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Alan Franciscus
HCV Advocate
HBV Advocate

Monday, February 13, 2012

Phase 3 Data on HEPLISAV(TM) in Adults Aged 18-55 Published in VACCINE

BERKELEY, CA, Feb 13, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation DVAX +1.98% announced today that results of a pivotal Phase 3 trial of HEPLISAV (HBV-10) were published online in the journal VACCINE. Data from this study will be used to support the HEPLISAV Biologics License Application (BLA) submission for an indication in adults 18-70 years of age. The article concludes that a short, two-dose regimen of HEPLISAV over 1 month was well-tolerated and induced superior immunogenicity and earlier onset of protection than a three-dose regimen of a licensed hepatitis B vaccine over 6 months. 

The article entitled "Comparison of Safety and Immunogenicity of Two Doses of Investigational Hepatitis B Virus Surface Antigen Co-administered with an Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide and Three Doses of a Licensed Hepatitis B Vaccine in Healthy Adults 18-55 Years of Age" describes the results from one of the two pivotal Phase 3 trials of HEPLISAV. Dr. Scott Halperin of Dalhousie University was the principal investigator and lead author. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B(R) in 2,415 adults randomized in a ratio of 3:1, HEPLISAV to Engerix-B. The seroprotection rate at the primary endpoint after 2 doses for HEPLISAV (95%) was significantly higher than after 3 doses for Engerix-B (81%). Superiority of the seroprotection rates for HEPLISAV was demonstrated at all time points measured. 

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