Ongoing Studies Listing
The HBV-25 post-marketing observational surveillance study began in August 2018 and will evaluate the occurrence of acute myocardial infarction (AMI) in approximately 30,000 patients who receive HEPLISAV-B® and approximately 30,000 patients who receive another hepatitis B vaccine. Patients will be followed through their electronic health records for 13 months. The study is being conducted in collaboration with Kaiser Permanente Southern California’s Center for Vaccine Safety and Effectiveness and is ongoing.
Title: Post-Marketing Observational Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who Receive HEPLISAV-B Compared with Another Hepatitis B Vaccine
The HBV-26 post-marketing observational surveillance study began in August 2018 and is evaluating the same patient population as the HBV-25 study for the occurrence of new-onset immune-mediated diseases, herpes zoster, and anaphylaxis. Patients will be followed for herpes zoster and immune-mediated diseases for 13 months. The study is being conducted in collaboration with Kaiser Permanente Southern California’s Center for Vaccine Safety and Effectiveness and is ongoing.
Title: Post-Marketing Observational Surveillance of the Safety of HEPLISAV-B in Adults 18 Years of Age and Older to Evaluate the Incidence of New Onset Immune-mediated Diseases, Herpes Zoster, and Anaphylaxis
The HEPLISAV-B pregnancy registry is an observational study being conducted in the United States to evaluate pregnancy outcomes in women vaccinated with HEPLISAV-B® within 28 days prior to conception or at any time during pregnancy. The purpose of the registry is to understand the effect of vaccination with HEPLISAV-B during pregnancy. The registry is sponsored by Dynavax Technologies and PPD, Inc.
Title: HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring
Toll-free number: 1-844-443-7734
ClinicalTrials.gov Identifier: NCT03664648
The HBV-24 Dialysis study is an open-label, single-arm trial being conducted in the United States to evaluate a new 4-dose regimen of HEPLISAV-B® in adults with end-stage renal disease (ESRD) who are undergoing hemodialysis and have not previously received a hepatitis B vaccine. The study is designed to evaluate the immunogenicity and safety of HEPLISAV-B over a 68-week period. The study is sponsored by Dynavax Technologies and DaVita Clinical Research and is ongoing.
Title: An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease Undergoing Hemodialysis
Phone number: 855-327-7883
ClinicalTrials.gov Identifier: NCT03934736