Dynavax Technologies Corporation announced final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021. The study, HBV-24, is an ongoing, open-label, single-arm trial being conducted in the United States to evaluate a new 4-dose regimen of HEPLISAV-B in adults with ESRD who are undergoing hemodialysis and have not previously received a hepatitis B vaccine. The study is designed to evaluate the immunogenicity of HEPLISAV-B at study week 20 and safety over the 68-week study duration. Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.