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. 2018 Apr 20;67(15):455-458.
doi: 10.15585/mmwr.mm6715a5.

Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant

Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant

Sarah Schillie et al. MMWR Morb Mortal Wkly Rep. .

Abstract

Hepatitis B (HepB) vaccination is the primary means of preventing infections and complications caused by hepatitis B virus (HBV). On February 21, 2018, the Advisory Committee on Immunization Practices (ACIP) recommended Heplisav-B (HepB-CpG), a yeast-derived vaccine prepared with a novel adjuvant, administered as a 2-dose series (0, 1 month) for use in persons aged ≥18 years. 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.

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Conflict of interest statement

No conflicts of interest were reported.

References

    1. Food and Drug Administration. Product approval information: package insert. Heplisav-B. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2018. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm...
    1. CDC. Prevention of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2018;67(No. RR-1). - PMC - PubMed
    1. CDC. New framework (GRADE) for development of evidence-based recommendations by the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2012;61:327. - PubMed
    1. Halperin SA, Dobson S, McNeil S, et al. Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults. Vaccine 2006;24:20–6. 10.1016/j.vaccine.2005.08.095 - DOI - PubMed
    1. Halperin SA, Ward B, Cooper C, et al. Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18–55 years of age. Vaccine 2012;30:2556–63. 10.1016/j.vaccine.2012.01.087 - DOI - PubMed

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