Dynavax completes phase 3 study of adult hepatitis B vaccine

Dynavax Technology Corp., a clinical-stage biopharmaceutical company reported Wednesday that it had completed a 12-month follow-up on all the subjects enrolled in its large scale Phase 3 study of HEPISLAV.

HEPISLAV is an investigational adult hepatitis B vaccine. The study was meant to evaluate immunogenicity in comparison to Energix, lot-to-lot consistency and safety. Dynavax said it expects to be able to report results within eight weeks.

Dynavax develops and discovers novel products to treat and prevent infectious and inflammatory diseases such as hepatitis B. HEPISLAV is meant to provide rapid and superior protection with fewer doses that vaccines that are currently licensed. Dynavax conducted the studies in an attempt to fulfill licensure requirements in the U.S., Canada and Europe.

Dynavax is developing the vaccine for large, high-value populations that are less responsive to current vaccines, such as individuals with chronic kidney disease. HEPISLAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist called ISS in an effort to enhance immune response.

According to the Centers for Disease Control and Prevention, Hepatitis B is a contagious liver disease that can range in severity from a mild illness that lasts a few weeks, to a serious, lifelong illness. The disease results from infection with the Hepatitis B virus. Chronic Hepatitis B affects close to 350 million people and contributes to around 620,000 deaths each year worldwide.