Dynavax Technologies Corp. (DVAX - Snapshot Report) commenced a new phase III study (HBV-23) on its hepatitis B vaccine candidate, Heplisav-B. Dynavax is seeking to get Heplisav-B approved in the U.S. and EU.
The randomized, active-controlled, HBV-23 (n=8,000) study will randomize (2:1) patients to receive a 2-dose series of Heplisav-B and 3-dose series of GlaxoSmithKline’s Engerix-B.
The primary endpoints of the study are for evaluation of the overall safety of the candidate and demonstrate the non-inferiority of the seroprotection rate induced by Heplisav-B compared with Engerix-B at week 28 in type II diabetes patients.
Secondary endpoints include safety profile of Heplisav-B with respect to specific outcomes and assessment of immunogenicity in subpopulations.