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Alan Franciscus
HCV Advocate

Tuesday, March 13, 2012

Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 Published in VACCINE

BERKELEY, CA, Mar 13, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation DVAX +3.37% announced today that results of an early Phase 3 trial (HBV-04) of HEPLISAV(TM) investigational hepatitis B vaccine were published online in the journal VACCINE. The article concludes that HEPLISAV was well-tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine. 

The article, entitled "Demonstration of Safety and Enhanced Seroprotection Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B(R) in 412 adults 40-70 years of age. The seroprotection rate at one month after the second dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p < 0.0001). At one month after the third dose, the seroprotection rates were 100% for HEPLISAV and 73% for Engerix-B (p < 0.0001). Seroprotection rates at one year after the first dose were 100% for HEPLISAV and 69% for Engerix-B (p < 0.0001). 

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