CDC: Recommendations on the Use of Heplisav-B Published

Benefits of protection with 2 doses administered over 1 month make the vaccine an important option for prevention of HBV
Benefits of protection with 2 doses administered over 1 month make the vaccine an important option for prevention of HBV

The Centers for Disease Control and Prevention (CDC) has published the Advisory Committee of Immunization Practices' (ACIP) recommendations regarding the use of Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]; Dynavax) for adults in the US. The recommendations are included in the Morbidity and Mortality Weekly Report (MMWR).

Heplisav-B vaccine combines the hepatitis B surface antigen with the Company's proprietary Toll-like receptor (TLR) 9 agonist, called the 1018 adjuvant, to enhance immune response. In February 2018, the ACIP recommended Heplisav-B be used in patients ≥18 years of age for vaccination against hepatitis B virus. The vaccine is administered as a 2-dose series (0, 1 month). 

Heplisav-B is the fifth inactivated hepatitis B vaccine currently recommended in the US. The ACIP decision was based on data from 4 randomized controlled trials assessing the prevention of hepatitis B virus infection and 6 randomized controlled trials assessing safety in adults. The data showed 90% to 100% of patients who received Heplisav-B achieved seroprotective anti-HBs levels vs 70.5% to 90.2% of patients who received Engerix-B (GlaxoSmithKline). 

Also, safety data among patients who received 2 or 3 doses of Heplisav-B (n=9,871) vs 3 or 4 doses of Engerix-B (n=4,385) were compared. Of the patients who received Heplisav-B, 45.6%, 5.4%, and 0.27% experienced a mild adverse event, serious adverse event, or cardiovascular event, respectively. 

Related Articles

The CDC states that current human data on Heplisav-B for pregnant women are insufficient to inform assessment of vaccine-associated risks in pregnancy. Until safety data are available, providers should use a hepatitis B vaccine from a different manufacturer. 

Heplisav-B contains HBsAg 20mcg + CpG 1018 3000mcg per 0.5mL dose and is intended for intramuscular (IM) injection. It is available in 1- and 5-count single-dose vials. 

For more information call (844) 375-4728 or visit CDC.gov.