The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has recommended the Heplisav-B (HepB-CpG) vaccine for the prevention of hepatitis B virus (HBV) in adults aged 18 years and older.
The ACIP issued its recommendation following the US Food and Drug Administration’s approval of the vaccine in November 2017.
The safety and efficacy of the vaccine was demonstrated in 4 randomized controlled trials (RCTs) that investigated HBV prevention, as well as 6 RCTs that examined adverse events associated with the vaccine.
A yeast-derived vaccine prepared with a novel adjuvant, Heplisav-B is administered in 2 doses over a 1-month period.
The vaccine is recommended especially for individuals with a risk of contracting HBV through sexual exposure, injection drug users, and patients with human immunodeficiency virus, among others.
However, the ACIP recommends that pregnant women receive an alternative HBV vaccine, since the safety of Heplisav-B has not yet been assessed in pregnancy.
Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant. MMWR Morb Mortal Wkly Rep 2018;67:455-458.