Berkeley, California, USA-based Dynavax Technologies Corp has reported statistically-significant results from the primary endpoint analysis of a Phase III trial comparing Heplisav, its hepatitis B virus vaccine, to UK drug major GlaxoSmithKline's Engerix-B vaccine in a difficult-to-immunize population of older adults.
The data show that, after three doses, Heplisav provided seroprotection to 100% of subjects versus 73.1% for Engerix-B (p<0.0001). The greatest difference in seroprotection after three doses was seen in subjects 56 to 70 years of age, where Heplisav provided 100% seroprotection and Engerix-B provided 56.1%. According to Dynavax, data for the entire study population show that, after two doses, Heplisav provided 98.5% seroprotection vs Engerix-B's 25%, as well as achieveing a level of immunity, as measured by geometric mean concentrations of anti-HBsAg, 18.5 times higher than Engerix-B, four weeks after the third dose.
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