In the trial, patients treated with the Dynavax vaccine showed 100% seroprotection compared with 90.5% seroprotection in the group treated with the GSK vaccine.
Results also showed that subjects treated with Heplisav experienced more durable seroprotection. At week 50, the Heplisav treated group still measured 100% seroprotection compared to 86% for the Engerix-B treated group.
The phase II/III trial was conducted in an older adult population, aged 40-70 years, in whom achieving seroprotection with conventional vaccine is more difficult than in younger adults.
The primary endpoint of the trial was seroprotection following three doses, and a key secondary endpoint was GMC, a measure of the robustness of antibody response. The safety profile of the vaccine was also favorable.
“The clear demonstration of superior efficacy of Heplisav in a patient population that is more difficult to immunize with conventional vaccine than younger individuals is a major achievement for Dynavax, and affirms our belief that Heplisav has the potential to provide meaningful clinical benefit to people in need of protection against exposure to hepatitis B,” said Dr Seng Gee Lim, National University Hospital, Singapore, and principal investigator for the clinical trial.