NEW ORLEANS – An investigational hepatitis B vaccine known as Heplisav-B provided significantly better seroprotection among adults with type 2 diabetes than did a currently licensed vaccine, based on results from a randomized phase III trial.
A total of 321 patients received three doses of the Food and Drug Administration–approved vaccine Engerix-B at weeks 0, 4, and 24, while 640 patients received two doses of the investigational vaccine Heplisav-B at weeks 0 and 4 and a placebo injection at week 24. In both groups of patients, two-thirds of subjects had diabetes for 5 or more years, Randall N. Hyer, MD, reported in a poster at the annual scientific sessions of the American Diabetes Association.
At 28 weeks, 90% of subjects in the Heplisav-B group and 65% in the Engerix-B group achieved seroprotection, defined as anti–hepatitis B titers of 10 mIU/mL or greater. The difference reached statistical significance. Among study participants aged 60-70 years, 85.8% of subjects in the Heplisav-B group achieved seroprotection, compared with 58.5% in the Engerix-B group. Among study participants with a body mass index of 30 kg/m2, 89.5% of subjects in the Heplisav-B group achieved seroprotection, compared with 61.4% in the Engerix-B group, reported Dr. Hyer, who is vice president of medical affairs for Dynavax, the maker of Heplisav-B.
The safety profile, including the incidence of immune-mediated adverse events, was similar in both treatment groups. The most frequently reported local reaction was injection-site pain, while the most common systemic reactions were fatigue, headache, and malaise.
Dynavax submitted a biologics license application to the FDA in March 2016, and a decision on whether to approve Heplisav-B is expected by mid-December. “The Centers for Disease Control and Prevention does recommend that all adults with diabetes aged 19-59 be vaccinated against HBV [hepatitis B virus] as soon as feasible after diagnosis. For folks 60 and above, it’s at the discretion of the physician. People with type 2 diabetes are twice as likely to get HBV,” Dr. Hyer said in an interview.
Dynavax funded the study. Dr. Hyer is an employee of the company.