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news.US based Dynavax Technologies has released results from a multi-center, observer-blinded HBV-16 Phase 3 trial evaluating two doses of Heplisav as compared to three doses of Engerix-B.
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The study aimed to establish whether the immunogenicity of two doses of Heplisav was non-inferior/superior to three doses of Engerix-B by comparing seroprotection rates (SPRs) at eight weeks post last dose.
The results of the trial demonstrated that the SPRs and Geometric Mean Concentrations (GMCs) in the Heplisav group were higher than the SPRs and GMCs in the Engerix-B group at every visit from Week 4 through Week 52.
In the trial, Heplisav provided earlier seroprotection than Engerix-B.
At the primary endpoint visit, Week 12 for Heplisav and Week 32 for Engerix-B, the SPR in the Heplisav group was 90% compared to 71% in the Engerix-B group.
Dynavax president and CMO Tyler Martin said the data clearly indicate that Heplisav induces an immune response that is faster, higher, and more durable than that produced by Engerix-B, with similar safety.
"These results, demonstrating the superiority of Heplisav to Engerix-B in a hyporesponsive population, will be the basis of our BLA filing that we intend to submit by the end of this year," Martin said.