On Apr. 20, 2018, the Centers for Disease Control and Prevention (CDC) published Immunization Practices Advisory Committee (ACIP) recommendations for use of hepatitis B vaccine with a novel adjuvant [Heplisav-B]. The ACIP Hepatitis Vaccines Work Group conducted a systematic review of the evidence, including data from four randomized controlled trials assessing prevention of HBV infection and six randomized controlled trials assessing adverse events in adults. Seroprotective antibody to hepatitis B surface antigen (anti-HBs) levels were achieved in 90.0%–100.0% of subjects receiving HepB-CpG (Dynavax Technologies Corporation), compared with 70.5%–90.2% of subjects receiving Engerix-B (GlaxoSmithKline Biologicals). The benefits of protection with 2 doses administered over 1 month make HepB-CpG an important option for prevention of HBV.

Vaccination is the primary means for preventing hepatitis B virus (HBV) infection and its complications. Existing hepatitis B (HepB) vaccines use an aluminum adjuvant. On November 9, 2017, Heplisav-B (HepB-CpG), a single-antigen HepB vaccine with a novel immunostimulatory sequence adjuvant, was approved by the Food and Drug Administration for the prevention of HBV in persons aged ≥18 years. The vaccine is administered as 2 doses, 1 month apart (1). On February 21, 2018, the Advisory Committee on Immunization Practices (ACIP) recommended HepB-CpG for use in persons aged ≥18 years.

HepB-CpG contains yeast-derived recombinant HepB surface antigen (HBsAg) and is prepared by combining purified HBsAg with small synthetic immunostimulatory cytidine-phosphate-guanosine oligodeoxynucleotide (CpG-ODN) motifs (1018 adjuvant). The 1018 adjuvant binds to Toll-like receptor 9 to stimulate a directed immune response to HBsAg (1).

HepB-CpG is available in single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HepB-CpG is formulated without preservatives and is administered as an intramuscular injection in the deltoid region of the upper arm.

HepB-CpG is the fifth inactivated HepB vaccine currently recommended for use in the United States. This report contains ACIP guidance specific to HepB-CpG and augments the 2018 ACIP recommendations for the prevention of HBV infection. This report does not include new guidance for populations recommended to receive HepB vaccination or immunization management issues other than those that pertain specifically to HepB-CpG. The intended audience for this report includes clinical and public health personnel who provide HepB vaccination services to adults. These recommendations are meant to serve as a source of guidance for health care providers; health care providers should always consider the individual clinical circumstances of each patient.