SAN DIEGO, CA—Two doses of the investigational hepatitis B
vaccine, HEPLISAV, administered over 4 weeks induced significantly
higher rates of and earlier seroprotection than Engerix-B given as 3
doses over 24 weeks, results of two pivotal Phase 3 trials concluded at
IDWeek 2012.
Two multicenter trials of the two vaccines were conducted to
determine immunogenicity in subjects in the age range for the proposed
indication for HEPLISAV, noted Robert Janssen, MD, from Dynavax
Technologies, Berkeley, CA. Dynavax has submitted a Biologics License
Application to the U.S. Food and Drug Administration for an indication
of prevention of hepatitis B infection in individuals 18 to 70 years
old.
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