Dynavax Presents Additional Phase 3 Data for HEPLISAV™ Hepatitis B Vaccine at EASL Medical Conference
News May 05, 2009
Dynavax Technologies Corporation has announced the oral presentation of additional Phase 3 clinical data for HEPLISAV™ hepatitis B vaccine in a session for late-breaking abstracts at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen, Denmark.
As previously reported, HEPLISAV met its primary endpoint in this Phase 3 trial and demonstrated the vaccine's potential to provide increased protection against hepatitis B viral infection and with fewer doses than the licensed vaccine.
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B® at 0, 1, and 6 months.
At each time point, there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.