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Heplisav offers superior seroprotection over Engerix-B: Dynavax

Dynavax Technologies said that its new hepatitis B vaccine candidate, Heplisav, given as two doses over four weeks has demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks.

Dynavax’s Heplisav is a TLR9 agonist and Engerix-B is a commercially available hepatitis B vaccine.

Dynavax’s Phase 3 Heplisav Short-regimen Trial (PHAST), a previously reported Phase 3 multicenter study evaluating adults with diabetes showed that at 12 weeks 84% of adult diabetics treated with Heplisav achieved seroprotection as compared to 0% of adult diabetics treated with Engerix-B.

At week 28, 93% of the Heplisav-treated group versus 35% in the Engerix-B group achieved seroprotection.

Heplisav’s significantly higher rate of seroprotection was achieved without further immunisation past four weeks while the Engerix-B group received a third immunisation at 24 weeks, Dynavax said.

According to the study the seroprotection rate of the Heplisav-treated group was 95% at week 12 and 81% at week 28 in the Engerix-B group is an indication of non-inferiority/superiority of Heplisav over Engerix-B.