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. 

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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. 

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