Heplisav-B Vaccine Description
The Heplisav-B vaccine combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), 9 agonists, to enhance the immune response. Dynavax's HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is an adult hepatitis B vaccine indicated to prevent infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
TLRs are expressed on dendritic cells and other innate immune cells and are among the most important receptors for eliciting a response to the presence of invading pathogens. Humans have 10 types of TLRs similar in structure but recognize different viruses or bacteria. By activating specific TLRs, it is possible to stimulate and control specific types of innate immune responses that can be harnessed to enhance adaptive responses and potentially improve vaccines and cancer-killing activities. Research at Dynavax has identified proprietary, synthetic oligonucleotides (short segments of DNA) that selectively and optimally activate these receptors.
HEPLISAV B is the only U.S. Food and Drug Administration (FDA) and European Commission-approved hepatitis B vaccine for adults with a two-dose regimen completed in one month. Dynavax has worldwide commercial rights to HEPLISAV-B.
Emeryville, California-based Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines.
Heplisav-B Vaccine Indication
The Heplisav-B vaccine is indicated for preventing infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is rising. There is no cure for hepatitis B, but effective vaccination can prevent it. In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
On December 15, 2020, the U.S. Preventive Services Task Force published a final recommendation statement on screening for hepatitis B virus infection in adolescents and adults. Based on its review of the evidence, the Task Force recommends that clinicians screen teens and adults at increased risk of hepatitis B infection to help prevent serious health problems.
Heplisav-B Vaccine Dosage
The heplisav-B vaccine is administered by intramuscular injection in the deltoid region. It is a 2-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. The full U.S. Prescribing Information for HEPLISAV-B, click here.
Heplisav-B Vaccine Side Effects
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%). Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Heplisav-B Vaccine News
May 27, 2021 - Dynavax Technologies announced it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B Vaccine in Germany, with an expected launch in the fourth quarter 2021. Bavarian Nordic is a fully integrated vaccines company focused on developing, manufacturing, and commercialization of life-saving vaccines.
April 27, 2021 - Dynavax Technologies Corporation announced the post-marketing study results assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results provide evidence that there is no increased risk of AMI associated with vaccination with HEPLISAV-B than Engerix-B.
February 19, 2021 - Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the European Medicines Agency Committee for Medicinal Products for Human Use positive opinion on its marketing authorization application.
January 7, 2021 - 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. In this clinical trial, final immunogenicity data in 119 patients evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease undergoing hemodialysis demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintaining 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.
December 15, 2020 - The U.S. Preventive Services Task Force member Chyke Doubeni, M.D., M.P.H, stated, “Evidence consistently shows that screening and early treatment leads to better health outcomes.” The Task Force’s final recommendation statement and corresponding evidence summary have been published online in the Journal of the American Medical Association and on the Task Force website at http://uspreventiveservicestaskforce.org.
December 10, 2020 - Dynavax Technologies Corporation announced that the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of HEPLISAV-B demonstrated by the safety and immunogenicity results from three Phase 3 clinical trials and post-marketing safety results.
April 28, 2020 - Dynavax Technologies Corporation reported immunogenicity and safety data from an interim analysis of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis showed HEPLISAV-B has well tolerated a seroprotection rate of 86.4% in 44 patients.
Heplisav-B Clinical Trials
Clinical Trials NCT03934736: Phase 1 Clinical Trial Heplisav-B in Adults With End-Stage Renal Disease 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). Last Update Posted: October 20, 2020.
Clinical Trial NCT04385524: Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection. Last Update Posted: May 13, 2020.