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免疫实践咨询委员会关于使用含新型佐剂的乙型肝炎疫苗的建议。

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

作者信息

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

出版信息

MMWR Morb Mortal Wkly Rep. 2018 Apr 20;67(15):455-458. doi: 10.15585/mmwr.mm6715a5.

DOI:10.15585/mmwr.mm6715a5
PMID:29672472
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6191098/
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.

摘要

乙型肝炎(乙肝)疫苗接种是预防乙肝病毒(HBV)感染及并发症的主要手段。2018年2月21日,免疫实践咨询委员会(ACIP)推荐使用Heplisav-B(乙肝-CpG),这是一种采用新型佐剂制备的酵母衍生疫苗,适用于≥18岁人群,采用两剂次程序(0月、1月)接种。ACIP乙肝疫苗工作组对相关证据进行了系统回顾,包括四项评估HBV感染预防的随机对照试验以及六项评估成人不良事件的随机对照试验的数据。接种Heplisav-B(Dynavax Technologies Corporation)的受试者中,90.0%-100.0%达到了乙肝表面抗原血清保护性抗体(抗-HBs)水平,而接种Engerix-B(葛兰素史克生物制品公司)的受试者中这一比例为70.5%-90.2%。在1个月内接种两剂次所带来的保护效益使乙肝-CpG成为预防HBV的重要选择。

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Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults.两种剂量的研究性乙型肝炎疫苗 HBsAg-1018 与已上市乙型肝炎疫苗在成人中的免疫原性比较:使用 Toll 样受体 9 激动剂佐剂
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