The lot-to-lot consistency trial will enroll approximately 2,000 patients in Canada and in the US, 1600 of whom will receive Heplisav, an investigational adult hepatitis B vaccine. Patients randomized to the comparator arm will receive Engerix-B, a currently licensed hepatitis B vaccine.
The initiation of the Canadian studies is expected to facilitate enrollment for the multi-center trials. Dynavax said that one trial is designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for Heplisav.
The second trial compares Heplisav to Engerix-B in patients with chronic kidney disease. These studies are directed toward fulfilling licensure requirements in Canada, in addition to the US and Europe. Reportedly, Heplisav has been shown in two previous Phase 3 trials to enhance protection rapidly and with fewer doses than a currently licensed vaccine.
The chronic kidney disease trial will enroll approximately 600 patients in Canada, the US and Germany, 300 of whom will receive Heplisav. Patients randomized to the comparator arm will receive Engerix-B.
Dynavax said that data from these trials are expected in mid-2011. The hepatitis B surface antigen in the Heplisav lots being evaluated was produced in Dynavax’s manufacturing facility in Dusseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.