www.fdanews.com/articles/179064-dynavax-issues-positive-phase-iii-results-for-hepatitis-vaccine-heplisav-b
Dynavax Issues Positive Phase III Results for Hepatitis Vaccine Heplisav-b
October 28, 2016
Dynavax has published subgroup results from the pivotal Phase III trial of its investigational hepatitis B vaccine, Heplisav-b.
The clinical analysis demonstrated that Heplisav-b, when administered as two doses over one month, brought significantly higher seroprotection rates than the approved hepatitis B vaccine Engerix-B, when administered as three doses over six months.
The study compared two doses of Heplisav-b over four weeks with three doses of Engerix-B over 24 weeks in 8,374 adults age 18 to 70.