Heplisav-B (HepB-CpG; Dynavax Technologies Corporation), a yeast-derived hepatitis B vaccine made with a novel adjuvant, is recommended for individuals aged 18 years and older, according to the Advisory Committee on Immunization Practices (ACIP).
The ACIP Hepatitis Vaccines Work Group conducted a systematic review of the evidence related to the immunogenicity and safety of HepB-CpG and implementation issues. ACIP voted unanimously to recommend the vaccine for adults on February 21, 2018.
Sarah Schillie, MD, from the Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, and colleagues describe the updated recommendations in an article published online April 19 in the Morbidity and Mortality Weekly Report.
The US Food and Drug Administration approved the vaccine November 10, 2017. It is given in two doses over the course of 1 month. Compliance with the entire vaccine regimen is a problem with other hepatitis B virus (HBV) vaccines, as they are given on a schedule of three doses over the course of 6 months.
“The benefits of protection with 2 doses administered over 1 month make HepB-CpG an important option for prevention of HBV,” the authors write.
The US Food and Drug Administration approval follows a review of the evidence at a meeting of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on July 30.
ACIP’s systematic review included data from four randomized controlled trials that assessed HBV infection prevention and six randomized controlled trials that assessed adverse events in adults who received the vaccine. Significantly more (90.0% – 100.0%) participants who received HepB-CpG achieved seroprotective antibody to hepatitis B surface antigen (anti-HBs) levels compared with those who received the Engerix-B (GlaxoSmithKline Biologicals) vaccine (70.5% – 90.2%).
Who Should Receive HepB-CpG
ACIP identifies several groups who should receive the vaccine, including those with high risk for infection through sexual exposure. These groups include sex partners of individuals who test positive for hepatitis B surface antigen; persons who are sexually active and not in a long-term, mutually monogamous relationship; those who are being evaluated or treated for a sexually transmitted infection; and men who have sex with men.
Individuals who are currently injecting drugs or have recently injected them should also receive the vaccine.
Those who are at risk for infection by percutaneous or mucosal blood exposure should be vaccinated as well. These include household contacts of individuals who are HbsAg-positive, residents and staff of facilities that care for developmentally disabled persons; healthcare and public safety workers who can reasonably expect to be at risk for blood exposure or contact with blood-contaminated body fluids; patients in predialysis and those undergoing hemodialysis, peritoneal dialysis, and home dialysis; patients with diabetes mellitus aged younger than 60 years; and patients with diabetes mellitus aged 60 years and older at the treating clinician’s discretion.
The vaccine should also be given to those traveling internationally to countries that have high or intermediate levels of endemic HBV infection or countries with HBsAg prevalence of 2% or higher.
Individuals with hepatitis C virus infection and those with chronic liver disease (including, but not limited to, persons with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase or aspartate aminotransferase level higher than twice the upper limit of normal) should receive the vaccine as well.
Others who should receive the vaccine include persons with HIV infection, incarcerated individuals, and those desiring protection against hepatitis B virus infection, regardless of whether they acknowledge a specific risk factor.
“Postlicensure surveillance studies and additional data pertaining to the use of HepB-CpG will be reviewed by ACIP as they become available, and recommendations will be updated as needed. Future economic analyses might inform cost-effectiveness considerations of HepB-CpG, including its use among persons at an increased risk for vaccine nonresponse,” the authors conclude.
The authors have disclosed no relevant financial relationships.
Morb Mortal Wkly Rep. Published online April 19, 2018. Full text
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