Dynavax Presents Promising Data on Hepatitis-B Vaccine, Heplisav-B, for Type 2 Diabetics

Dynavax Presents Promising Data on Hepatitis-B Vaccine, Heplisav-B, for Type 2 Diabetics

Dynavax Technologies Corp. presented preliminary data from a Phase 3 study of its Heplisav-B vaccine against hepatitis B in adults with type 2 diabetes mellitus, showing the vaccine provided a higher rate of protection with fewer doses than an approved vaccine with a similar safety profile (Engerix-B).

The data presentation was made at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), held June 10–14 in New Orleans.

HBV-23 (NCT02117934) is a potentially pivotal study evaluating the safety and immunogenicity of the investigational vaccine, Heplisav-B, compared with Engerix-B in adults ages 18 to 70. Heplisav-B participants received two doses, at zero and one month, and Engerix-B participants received three doses, at zero, one, and six months in the trial, which concluded late last year.

More than 8,300 adults were randomly assigned 2:1 to receive Heplisav-B or Engerix-B. Of the 1,144 adults with type 2 diabetes, two-thirds had diabetes for five or more years. Participants were stratified by age, study site and diabetes status. Seroprotection was defined as anti-HBs of 10 mIU/mL or greater.

Results indicated that the seroprotection rate was significantly higher in participants who received vaccination with Heplisav-B (90%) compared with Engerix-B (65.1%).

Larger differences were observed in participants age 60 to 70, with Heplisav-B demonstrating an 85.8% seroprotection rate compared to 58.5% with Engerix-B. For participants with a body mass index greater than or equal to 30, the rate of seroprotection with Heplisav-B was 89.5% compared to 61.4% for Engerix-B.

Reported adverse events were similar between both vaccine groups. Immune-mediated adverse events were evaluated by an independent Safety Evaluation and Adjudication Committee, and found to be unrelated to vaccination with Heplisav-B.

“The hepatitis B virus can spread easily through contact with contaminated medical equipment, such as blood glucose monitors, posing a serious health risk to people living with diabetes,” Rob Janssen, chief medical officer for Dynavax, said in a press release. “Results of this study show that, with two doses over one month, HEPLISAV-B provided a significantly higher rate of seroprotection in participants with type 2 diabetes than an existing hepatitis B vaccine.”

Heplisav-B is an adult hepatitis B vaccine combining hepatitis B surface antigen with a toll-like receptor 9 agonist to boost the immune response. 

The U.S. Food and Drug Administration (FDA) is expected to decide on the Biologics License Application submitted by the company for Heplisav-B on or before Dec. 15.

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