Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant.

Schillie, Sarah; Harris, Aaron; Link-Gelles, Ruth; Romero, José; Ward, John; Nelson, Noele

doi:10.15585/mmwr.mm6715a5

Cited by 208Hepatitis B Virus StudiesIntramuscular injections and effectsCervical Cancer and HPV Research

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Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant.

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Schillie, Sarah, Harris, Aaron, Link-Gelles, Ruth, Romero, José, Ward, John, Nelson, Noele·2018·MMWR Morbidity and Mortality Weekly Report

DOI 10.15585/mmwr.mm6715a5PMC PMC6191098

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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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High vaccination coverage rates with subsequent decreases in acute HBV infection incidence have been achieved among infants and adolescents.
“High vaccination coverage rates with subsequent decreases in acute HBV infection incidence have been achieved among infants and adolescents (1318).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1318]
The opening section says hepatitis B vaccination prevents infection, and the Summary of Key Findings reports seroprotection in adult vaccine trials. Neither reports vaccination coverage among infants and adolescents or a subsequent decline in acute HBV incidence; searches for those terms found no such passage in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
For each 1.1 million doses of vaccine administered, approximately one recipient will experience anaphylaxis; however, no deaths have been reported among these patients.
“For each 1.1 million doses of vaccine administered, approximately one recipient will experience this type of reaction (1328); however, no deaths have been reported among these patients (1318,1328).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1318]
The Summary of Key Findings reports overall adverse-event rates for hepatitis B vaccines, but not anaphylaxis rates or deaths among recipients with anaphylaxis. Searches for anaphylaxis, 1.1 million doses, and fatalities found no passage in our copy addressing either part of the claim. (LLM, conf=0.76)
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Authors: Schillie, S., Harris, A., Link-Gelles, R., Romero, J., Ward, J., & Nelson, N.
Affiliations: Arkansas Children's Hospital (US)
Corresponding author: Schillie, Sarah
ORCID: Schillie, Sarah
Harris, Aaron
Ward, John
Nelson, Noele
Venue: MMWR Morbidity and Mortality Weekly Report
Publisher: Centers for Disease Control MMWR Office
Published: 2018-04-20
Volume: 67
Issue: 15
Pages: 455-458
ISSN: 0149-2195 (ISSN-L)
1545-861X
DOI: 10.15585/mmwr.mm6715a5
PMC: PMC6191098
OpenAlex: W2800687120
Cited by: 208
References: 9
Citations by year: 2026: 16 · 2025: 15 · 2024: 19 · 2023: 21 · 2022: 25 · 2021: 37 · 2020: 42 · 2019: 25 · 2018: 8
FWCI: 21.84
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: MMWR Morbidity and Mortality Weekly Report (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Funders: U.S. Department of Health and Human Services
University of Arkansas
University of Arkansas for Medical Sciences
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Topics: Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
Keywords: hepatitis B vaccine, CpG adjuvant, hepatitis B prevention, adult vaccination, seroprotection, anti-HBs antibodies, vaccine adverse events, Engerix-B, Advisory Committee on Immunization Practices recommendations
MeSH terms: Adjuvants, Immunologic, Adolescent, Adult, Centers for Disease Control and Prevention, U.S., Hepatitis B, Humans, Immunization Schedule, United States, Randomized Controlled Trials as Topic, Hepatitis B Vaccines, Practice Guidelines as Topic, Advisory Committees

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Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant.

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