Dynavax Technologies has announced the initiation of a Phase I clinical trial of Heplisav, its ISS-based hepatitis B (HBV) vaccine in patients with end-stage renal failure (pre-dialysis). The trial will be conducted at multiple centers in the U.S. and will compare Heplisav to GlaxoSmithKline's Engerix-B vaccine. The trial is designed to yield safety, tolerability, pharmacokinetic and efficacy data and is anticipated to be completed within 12 to 18 months.
The trial will enroll 96 patients with diagnosed chronic renal failure, aged 40 or older, who are seronegative for HBV and who have not been previously vaccinated against HBV. Patients will be randomized in a three-to-one ratio, Heplisav to Engerix-B, and dosed in three sequential, dose-escalating cohorts of 32 patients. The trial will compare three immunizations with Heplisav with four immunizations with Engerix-B. Heplisav-treated patients will receive immunizations at weeks zero, four and 24, and a placebo injection at week eight. Engerix-B-treated patients will receive immunizations with the vaccine on the same zero-, four-, eight- and 24-week schedule.