According to the protocol, all patients will receive immunizations over a period of six months, with the primary endpoint evaluated at month 7. The primary endpoint of the study is non-inferiority of three injections of HEPLISAV at times 0, 1 and 6 months versus eight injections of Engerix-B® consisting of double doses at times 0, 1, 2 and 6 months.
Tyler Martin, M.D., President and Chief Medical Officer of Dynavax, noted, "Completion of enrollment in this trial is another important milestone in the development of HEPLISAV and keeps us on track for BLA submission in Q4 2011. We expect the last immunizations to be administered in June 2011."
In September, 2010, Dynavax reported that the first subjects enrolled in the Phase 3 chronic kidney disease study were 12 months past their first dose, and that no safety issues had been identified by the DSMB monitoring safety of the trial. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.