Positive results have been reported from HBV-23, a phase 3 trial of the investigational hepatitis B vaccine Heplisav-B (Dynavax Technologies Corporation) compared with a currently marketed vaccine, Engerix-B (hepatitis B vaccine [recombinant], GlaxoSmithKline), in more than 8,000 adults 18 to 70 years of age.
The Heplisav-B cohort received two doses, at zero and one month, and the Engerix-B cohort received three doses, at zero, one, and six months. The study had two co-primary endpoints: the overall safety of Heplisav-B with respect to clinically significant adverse events, and the noninferiority of seroprotection in participants with type-2 diabetes mellitus. Both co-primary endpoints were met.
Results from the safety evaluation included the following:
The safety database for Heplisav-B now includes a total of 10,038 participants.
Immunogenicity data from the trial demonstrated that the peak seroprotection rate (SPR) in participants with type-2 diabetes mellitus who received Heplisav-B was 90% compared with 65% for Engerix-B, demonstrating noninferiority and a significantly higher percentage of seroprotection provided by Heplisav-B compared with Engerix-B.
In additional secondary endpoints:
Heplisav-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 (TLR9) agonist to enhance the immune response.
Dynavax plans to resubmit the Heplisav-B biologics license application (BLA) at the end of the first quarter of 2016 and anticipates a six-month review by the FDA. In the revised BLA, the company plans to address all issues raised by the FDA in a February 2013 complete response letter (CRL) by submitting the results of the HBV-23 trial, integrated with previous clinical data, and responses to chemistry, manufacturing, and controls (CMC) issues in the CRL.
Source: Dynavax; January 7, 2016.