Dynavax Technologies Corporation (NASDAQ: DVAX) announced initiation of a large-scale Phase 3 trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV™, the Company's investigational adult hepatitis B vaccine. This study and the ongoing Phase 3 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 3 trials to enhance protection more rapidly 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…