HEPLISAV-B Vs. Engerix-B Comparison Published

California-based Dynavax Technologies Corporation today announced the post-marketing study results assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response.

The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the occurrence of AMI in approximately 31,000 patients who received HEPLISAV-B® and approximately 38,000 patients who received Engerix-B.

The AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B.

The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint.
Thus, these results provide evidence that there is no increased risk of AMI associated with vaccination with HEPLISAV-B than Engerix-B.

"These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," commented Robert Janssen, M.D., Chief Medical Officer, Dynavax, in a press statement.

"We are pleased to collaborate with Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness and appreciate their rigorous conduct of this study."

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent the disease, says the U.S. CDC.

In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas.

Dynavax is a commercial-stage biopharmaceutical company located in Emeryville, CA, developing and commercializing novel vaccines.