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B群脑膜炎球菌结合疫苗(MenB-FHbp)使用的更新建议 - 免疫实践咨询委员会,2016年

Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine - Advisory Committee on Immunization Practices, 2016.

作者信息

Patton Monica E, Stephens David, Moore Kelly, MacNeil Jessica R

出版信息

MMWR Morb Mortal Wkly Rep. 2017 May 19;66(19):509-513. doi: 10.15585/mmwr.mm6619a6.

Abstract

Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10-25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C (Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended use of MenB vaccines among certain groups of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease* (Category A) (3), and in June 2015, ACIP recommended that adolescents and young adults aged 16-23 years may be vaccinated with MenB vaccines to provide short-term protection against most strains of serogroup B meningococcal disease (Category B) (4). Consistent with the original Food and Drug Administration (FDA) licensure for the two available MenB vaccines, ACIP recommended either a 3-dose series of MenB-FHbp or a 2-dose series of MenB-4C. Either MenB vaccine can be used when indicated; ACIP does not state a product preference. The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses in a series. In April 2016, changes to the dosage and administration of MenB-FHbp were approved by FDA to allow for both a 2-dose series (administered at 0 and 6 months) and a 3-dose series (administered at 0, 1-2, and 6 months) (5,6). In addition, the package insert now states that the choice of dosing schedule depends on the patient's risk for exposure and susceptibility to serogroup B meningococcal disease. These recommendations are regarding use of the 2- and 3-dose schedules of MenB-FHbp vaccine (Trumenba) and replace previous ACIP recommendations for use of MenB-FHbp vaccine published in 2015 (3,4). Recommendations regarding use of MenB-4C (Bexsero) are unchanged (3,4).

摘要

目前,两种B群脑膜炎球菌(MenB)疫苗已获美国食品药品监督管理局(FDA)批准,可用于10至25岁人群。这两种疫苗分别是MenB-FHbp(Trumenba,辉瑞公司)(1)和MenB-4C(Bexsero,葛兰素史克生物制品公司)(2)。2015年2月,免疫实践咨询委员会(ACIP)建议,对于某些≥10岁且感染B群脑膜炎球菌病风险增加的人群*(A类)(3),使用MenB疫苗;2015年6月,ACIP建议,16至23岁的青少年和年轻人可接种MenB疫苗,以提供针对大多数B群脑膜炎球菌病菌株的短期保护(B类)(4)。与FDA最初对两种可用MenB疫苗的许可一致,ACIP建议接种3剂次的MenB-FHbp或2剂次的MenB-4C。如有需要,两种MenB疫苗均可使用;ACIP未表明对产品的偏好。这两种MenB疫苗不可互换;同一系列的所有剂次必须使用相同的疫苗产品。2016年4月,FDA批准了MenB-FHbp的剂量和接种方案变更,允许采用2剂次系列(0月和6月各接种1剂)和3剂次系列(0月、1至2月和6月各接种1剂)(5,6)。此外,药品说明书现在指出,接种方案的选择取决于患者接触B群脑膜炎球菌病的风险和易感性。这些建议涉及MenB-FHbp疫苗(Trumenba)2剂次和3剂次接种方案的使用,取代了ACIP 2015年发布的关于MenB-FHbp疫苗使用的先前建议(3,4)。关于MenB-4C(Bexsero)使用的建议保持不变(3,4)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb89/5657641/c35333892e95/mm6619a6-F1.jpg

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