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支持青少年和年轻成人接种 2 剂 MenB-FHbp(一种二价脑膜炎奈瑟菌 B 群疫苗)的临床数据。

Clinical data supporting a 2-dose schedule of MenB-FHbp, a bivalent meningococcal serogroup B vaccine, in adolescents and young adults.

机构信息

Pfizer Vaccine Clinical Research and Development, Hurley, UK.

Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.

出版信息

Vaccine. 2018 Jun 27;36(28):4004-4013. doi: 10.1016/j.vaccine.2018.05.060. Epub 2018 Jun 1.

Abstract

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis is a potentially devastating condition that can result in death and is associated with serious long-term sequelae in survivors. Vaccination is the preferred preventative strategy. Quadrivalent polysaccharide-based vaccines that protect against infection caused by meningococcal serogroups A, C, W, and Y are not effective against meningococcal serogroup B (MenB), which was responsible for approximately 60% and 35% of confirmed IMD cases in the European Union and the United States in 2016, respectively. A recombinant protein MenB vaccine (MenB-FHbp [bivalent rLP2086; Trumenba®]) has been approved for protection against MenB infection in persons 10-25 years of age in the United States and Canada and for individuals ≥10 years of age in the European Union and Australia. In these regions, MenB-FHbp is approved as a 2- or 3-dose primary vaccination schedule. This report will review the current evidence supporting administration of MenB-FHbp as a 2-dose primary vaccination schedule. Different contexts in which a 2- or 3-dose primary vaccination schedule might be preferred (eg, routine prospective vaccination vs outbreak control) are reviewed.

摘要

侵袭性脑膜炎球菌病(IMD)由脑膜炎奈瑟菌引起,是一种潜在的破坏性疾病,可导致死亡,并与幸存者的严重长期后遗症相关。疫苗接种是首选的预防策略。针对脑膜炎奈瑟菌血清群 A、C、W 和 Y 感染的四价多糖疫苗对血清群 B(MenB)无效,2016 年,MenB 分别导致欧盟和美国约 60%和 35%的确诊 IMD 病例。一种重组蛋白 MenB 疫苗(MenB-FHbp[双价 rLP2086;Trumenba®])已获准在美国和加拿大用于保护 10-25 岁人群免受 MenB 感染,在欧盟和澳大利亚用于≥10 岁人群。在这些地区,MenB-FHbp 获准作为 2 剂或 3 剂初级免疫接种方案使用。本报告将回顾支持 MenB-FHbp 作为 2 剂初级免疫接种方案的现有证据。还回顾了不同情况下可能首选 2 剂或 3 剂初级免疫接种方案的情况(例如,常规前瞻性疫苗接种与暴发控制)。

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