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news.Dynavax Technologies (Dynavax) has started the 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.
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The study and the ongoing Phase 3 trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the US, 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.
Reportedly, The lot-to-lot consistency trial is expected to enroll 2,000 patients in Canada and in the US, 1600 of whom will receive Heplisav. Wherein, patients who are randomised to the comparator arm will receive Engerix-B, a currently licensed hepatitis B vaccine.
The primary objectives of the study 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. Additionally, the secondary objectives include the safety of Heplisav as compared to Engerix-B.
The company said that the data from the 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 Dsseldorf, Germany. The facility was recently upgraded and licensed in the EU for commercial production of hepatitis B surface antigen.