Dynavax Initiates Large-Scale Phase III Trial of HEPLISAV™
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This study and the ongoing Phase III trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. HEPLISAV has been shown in two pivotal Phase III trials to enhance protection and with fewer doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll 2,000 patients in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B®, a currently licensed hepatitis B vaccine. The primary objectives are:
• Non-inferiority of the immune response to HEPLISAV vaccination as measured by the seroprotection rate at 8 weeks after the last active dose, compared to Engerix-B vaccination at 8 weeks after the last active dose; and
• Lot-to-lot consistency for immune response as measured by geometric mean concentration at 4 weeks after the last active dose among 3 consecutively manufactured lots of HEPLISAV.
The secondary objectives include the safety of HEPLISAV as compared to Engerix-B.
Data from this trial is expected in the first half of 2011. The hepatitis B surface antigen in the HEPLISAV lots being evaluated was produced in Dynavax's manufacturing facility in Duesseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.