Dynavax Technologies presented additional Phase III data showing that the Heplisav hepatitis B vaccine met the primary endpoints in a Phase III trial, at the annual meeting of the European Association for the Study of Liver Disease in Copenhagen, Denmark.
The PHAST study seroprotection rate at the primary endpoint was 95% in subjects receiving two doses of Heplisav at baseline and one month, compared to 81% in patients receiving three doses of the vaccine Engerix-B. At each time point, there was a statistically-significant (p<0.0001) difference in the seroprotection rate for those receiving Heplisav or Engerix-B.
As previously reported, safety results from this trial demonstrated the safety profile of Heplisav and Engerix-B appeared similar. Subjects were randomized three to one to receive Heplisav or Engerix-B.
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