Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV™ vs. Engerix-B®
Immunogenicity data demonstrated:
- At the primary endpoint, 8 weeks post the last dose of vaccine, 12 weeks for HEPLISAV and 32 weeks for Engerix-B, the seroprotection rate (SPR) was 90% for HEPLISAV and 70% for Engerix-B, demonstrating the non-inferiority and superiority of HEPLISAV to Engerix-B.
- The peak SPR for HEPLISAV occurred at 24 weeks and was 95%. The peak SPR for Engerix-B occurred at 28 weeks and was 73%.
- At the final visit, week 52, 48 weeks after the last dose of HEPLISAV and 28 weeks after the last dose of Engerix-B, the SPRs were 92% for HEPLISAV and 59% for Engerix-B.
- 50% of HEPLISAV subjects and 53% of Engerix-B subjects experienced an adverse event.
- 7% of HEPLISAV subjects and 6% of Engerix-B subjects experienced possibly related adverse events.
- 4% of HEPLISAV subjects and 5% of Engerix-B subjects experienced a serious adverse event.
- 3 new onset autoimmune adverse events were confirmed by the
Safety Evaluation and Adjudication Committee (SEAC), none of which were serious adverse events. All three occurred in the HEPLISAV group, consistent with the 4:1 randomization.
- There were no cases of ANCA-associated vasculitis or Wegener's Granulomatosis.
With respect to the consistency analysis of three consecutively manufactured lots of HEPLISAV,
- By Geometric Mean Antibody Concentration (GMC), the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks, the pre-specified primary endpoint. The GMC of one HEPLISAV lot was slightly higher than the other two lots, which resulted in not meeting the consistency criteria at week 8.
- By SPR, the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks.
- At all of these timepoints, each lot of HEPLISAV was superior to Engerix-B.
"These results confirm and expand the superiority of HEPLISAV vs. Engerix-B in this hyporesponsive population of persons age 40 and above. HEPLISAV again demonstrated the rapid onset of seroprotection and superior peak protection compared to Engerix-B. A new finding in this trial is the superior duration of HEPLISAV to Engerix-B. Based on the results of intensive safety monitoring over 12 months, we have again demonstrated that HEPLISAV has a similar safety profile to Engerix-B, generally considered to be a very safe vaccine. Finally, we believe the consistency of the peak immune response of three lots of HEPLISAV was clearly demonstrated in this trial," commented
Webcast and Conference Call Today
HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including statements regarding our expectation of confirmation in the near future by the
Engerix-B® is a registered trademark of GlaxoSmithKline
Michael Ostrach Vice President and Chief Business Officer 510-665-7257 Email Contact
News Provided by Acquire Media