Recommendations of the ACIP for use of a hepatitis B vaccine with a novel adjuvant

Hepatitis B vaccination (HepB) is key to the prevention of the virus and associated complications. While most existing vaccines use an aluminum adjuvant, CDC's Advisory Committee on Immunization Practices (ACIP) this February recommended a yeast-derived formulation prepared with a novel immunostimulatory sequence adjuvant.

Hepatitis B vaccination (HepB) is key to the prevention of the virus and associated complications. While most existing vaccines use an aluminum adjuvant, CDC's Advisory Committee on Immunization Practices (ACIP) this February recommended a yeast-derived formulation prepared with a novel immunostimulatory sequence adjuvant. FDA approved the HepB-CpG vaccine (Dynavax Technologies) last November—making it the fifth inactivated HepB vaccine sanctioned in the United States—and reached the decision to endorse it after a systematic review of the evidence. The literature included four randomized controlled trials evaluating prevention of HBV infection and six assessing adverse events in adult patients. Outcomes with HepB-CpG were compared with outcomes from Engerix-B (GlaxoSmithKline Biologicals). Based on the results, ACIP recommends HepB-CpG for adults aged 18 years and older. The vaccine is to be administered in 2 doses, with a 1-month buffer in between; and both doses should consist of HepB-CpG, rather than interchanging brands. Moreover, for recipients who took a single earlier dose of vaccine from another manufacturer, the 2-dose HepB-CpG regimen is still effective when administered at least 4 weeks apart. ACIP does not note any special considerations for pregnant women. However, serologic testing is advised 1–2 months after the last dose in patients who are immunocompromised, have HIV, health care workers, and intimate partners of individuals who test positive for HepB surface antigens. Results will gauge the response to vaccination as well as the need for revaccination.