Dynavax begins late-stage hepatitis B vaccine test

Dynavax Technologies Corporation has enrolled over 500 patients in a late-stage test of the hepatitis B vaccine called Heplisav for people with chronic kidney disease in 69 different locations in Germany, Canada and the United States.

Patients will be immunized three times over the course of six months, reports. The primary endpoint effectiveness for the Phase III trial is expected be studied at seven months. The hope is that Heplisav is classified as "non-inferior" to GlaxoSmithLine's Enegerix-B vaccine.

Dynavax has conducted nine clinical trials over the past decade, which have involved close to 2,500 individuals. The company hopes to target unmet medical needs of end-stage renal disease patients and adults by providing higher protection with fewer doses.

The vaccine is based on proprietary immunostimulatory sequences that target  the Toll-like Receptor 9 in an effort to stimulate an innate immune response.

Hepislav combines a hepatitis B surface antigen with the first generation 1018 ISS.

Two Investigational New Drug Applications for Hepislav are currently on U.S. FDA clinical hold.

The final immunizations for the current trial will be given in June.

Hepatitis B is a chronic disease that may lead to hepatocellular carcinoma and cirrhosis of the liver. While there is no cure for hepatitis B, disease prevention through effective vaccines can limit its spread.