Dynavax begins trial of hepatitis vaccine

The trial will be conducted at multiple centers in the US 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. In previous trials Heplisav has proved superior to Engerix-B.

Heplisav is based on Dynavax’s proprietary immunostimulatory sequence (ISS) that specifically targets toll-like receptor 9 (TLR-9) to stimulate an innate immune response. Heplisav combines ISS with hepatitis B vaccine (HBV) surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection.

The phase I 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 the virus. Patients will be randomized in a 3:1 ratio, Heplisav to Engerix-B, and dosed in three sequential, dose-escalating cohorts of 32 patients.

The primary endpoint is safety and tolerability through to the final week of the trial. The secondary endpoints are seroprotection and geometric mean concentrations four weeks after each immunization. A pharmacokinetic analysis will be performed on a subset of trial participants. All trial participants will be followed for 50 weeks.

“We believe that the dialysis population is largely undeserved by current hepatitis B vaccines and that Dynavax’s Heplisav could offer meaningful medical benefits to these patients who are at high risk of infection,” said Dan Levitt, chief medical officer.