MONDAY, MARCH 19, 2018

Immunizations for Phase 3 study of hepatitis B vaccine complete

Dynavax Technologies reports that it has completed immunizing over 2,000 subjects in a Phase 3 study of HEPLISAV, an adult hepatitis B vaccine.

The study will be completed in a year, and the vaccine will likely be submitted for biologics licensure application approval, the company said in a news release.

In an already completed Phase 3 trial, Dynavax reports that HEPLISAV demonstrated "increased, rapid protection with fewer doses than current licensed vaccines." 

The HEPLISAV vaccine enhances the immune system response to hepatitis B by combining hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist that is called ISS, the company states.

While it continues the process of seeking American, Canadian and European approval, Dynavax says the vaccine is being developed for people who are less responsive to currently licensed hepatitis B vaccines, including those with chronic kidney disease, HIV or chronic liver disease.

Hepatitis B vaccines on the market now require three doses over six months for healthy patient populations to become immune to the virus, Dynavax says. HEPISLAV, the company says, will require fewer doses over a shorter time period if it is approved.

Hepatitis B, is a liver infection caused by the hepatitis B virus and can for some lead to liver failure, liver cancer or cirrhosis of the liver.