Heplisav-B combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), 9 agonist, to enhance the immune response.
Heplisav-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Heplisav-B is administered by intramuscular injection in the deltoid region.
It is a two-dose series given one month apart.
Heplisav-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
Heplisav-B Clinical Trials
Clinical Trials NCT03934736: Phase 1 Clinical Trial Heplisav-B in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Clinical Trial NCT04199715: Phase 1 Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients
Clinical Trial NCT03685708: Phase 2 HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
Clinical Trial NCT04193189: Phase 3 B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B (BEe-HIVe)
Clinical Trial NCT04385524: Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection