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Results from a post hoc analysis of data from the Phase 3 HBV 23 trial showed that Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]; Dynavax Technologies) was well-tolerated and induced high rates of seroprotection in older patients with type 2 diabetes. The full findings were presented at the American Diabetes Association (ADA) Annual Meeting in Orlando, FL.
HBV 23 (N=8374) was a randomized, observer-blinded, active-controlled, multicenter study that evaluated 2 doses of Heplisav-B over 4 weeks vs 3 doses of Engerix-B (hepatitis B vaccine [recombinant]; GlaxoSmithKline) over 24 weeks in adults aged 18 to 70 years. For the analysis, study authors looked at data specifically for patients with type 2 diabetes aged 60 to 70 years.
The data showed a seroprotection rate of 85.8% at week 28 with Heplisav-B vs 58.5% for Engerix-B (treatment difference 27.3%, 95% CI, 18.0%-36.8%). In addition, administration of Heplisav-B resulted in higher geometric mean concentration (GMCs) at week 24 vs Engerix-B at week 28 (GMC ratio 2.7, 95% CI, 1.6-4.4).
When comparing the seroprotection rate at week 28 for both vaccines among adults with type 2 diabetes aged 18 to 70 years, Heplisav-B demonstrated a higher rate vs Engerix-B (90.0% vs 65.1%).
Regarding safety, Heplisav-B and Engerix-B demonstrated similar profiles regardless of the patient subgroup. A medically attended adverse event (MAE) was seen in 64.2% of patients in the Heplisav-B group vs 55.6% of patients in the Engerix-B group.
“These data in elderly diabetic patients show the benefit of Heplisav-B in a population that is more difficult to protect and, when infected, typically demonstrates a more severe hepatitis B disease,” said Dr. Rob Janssen, chief medical officer of Dynavax.
Heplisav-B vaccine combines hepatitis B surface antigen with the Company’s proprietary Toll-like receptor (TLR) 9 agonist to boost immune response. It is available as 0.5mL single-dose vials in 1- and 5-count cartons.
For more information visit HeplisavB.com.
