Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved November 2017

Specific Treatments:

hepatitis B virus

Find Related Trials for The Following Conditions

General Information

Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Heplisav-B is specifically indicated for prevention of infection caused by all known subtypes of hepatitis B virus for use in adults 18 years of age and older. 

Heplisav-B is supplied as a solution for intramuscular injection. The recommended dose is two doses (0.5 mL each) administered one month apart.

Clinical Results

FDA Approval

The FDA approval of Heplisav-B was based on data from three Phase III non-inferiority trials of nearly 10,000 adults who received Hpelisav-B. The pivotal studies compared Heplisav-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase III trial, which included 6,665 subjects, showed that Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis of 961 subjects with type II diabetes, Heplisav-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B. 

Side Effects

Adverse effects associated with the use of Heplisav-B may include, but are not limited to, the following:

  • injection site pain
  • fatigue
  • headache

Mechanism of Action

Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Additional Information

For additional information regarding Heplisav-B or the prevention of hepatitis B, please visit http://heplisavb.com/