User login
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.
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.
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.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Compared with Engerix-B, Heplisav-B protected more subjects with diabetes against hepatitis B.
Major finding: At 28 weeks, 90% of the Heplisav-B group and 65% of the Engerix-B group had anti–hepatitis B titers of 10 mIU/mL or greater.
Data source: A phase III randomized trial in which 321 patients received three doses of Engerix-B at weeks 0, 4, and 24, while 640 patients received two doses of Heplisav-B at weeks 0 and 4 (plus placebo at week 24).
Disclosures: Dynavax funded the study. Dr. Hyer is an employee of the company.
