Dynavax Completes HEPLISAV-B Phase 3 Trial Enrollment - Quick Facts

(RTTNews) - Dynavax Technologies Corp. (DVAX) Monday said it has completed the planned enrollment in its ongoing phase 3 clinical study of HEPLISAV-B, investigational adult hepatitis B vaccine. The trial enrolled more than 8,250 adults, including over 1,100 diabetic subjects, at 40 sites in the U.S.

The trial, known as HBV-23, aims to provide an adequately-sized database of vaccinated subjects, for enabling the U.S. Food and Drug Administration or FDA to complete its review of the pending HEPLISAV-B Biologics License Application. In addition, the study will evaluate the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus.

HBV-23, an observer-blinded, randomized, active-controlled trial, will have adult patients between the ages of 18 and 70 randomized in a 2:1 ratio, to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B. Safety follow up will continue for 12 months following each subject's second vaccination. The company said all study visits will be completed by October, 2015.