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一种多组份 B 群脑膜炎球菌疫苗在欧洲获准使用:我们对此了解多少,还有哪些方面有待了解?

A multicomponent serogroup B meningococcal vaccine is licensed for use in Europe: what do we know, and what are we yet to learn?

机构信息

Department of Paediatrics, University of Oxford, Old Rd, Headington, Oxford, OX37LE, UK.

出版信息

Expert Rev Vaccines. 2013 Aug;12(8):837-58. doi: 10.1586/14760584.2013.814862.

Abstract

The first meningococcal vaccine with the potential to provide broad coverage against serogroup B disease has recently been approved for use in Europe. This vaccine, multi-component serogroup B vaccine (4CMenB), contains recombinant proteins and outer membrane vesicles, and has been extensively studied in clinical trials involving over 7500 adults, children and infants. As well as demonstrating immunogenicity against a range of serogroup B meningococcal strains, these trials have also demonstrated relatively high rates of fever following infant immunization. This article will summarize the vaccine composition, clinical trials and suggested schedules of this vaccine, with specific attention to immunogenicity, reactogenicity, safety, potential coverage and optimal implementation of this vaccine.

摘要

最近,一种有可能对 B 群脑膜炎球菌病提供广泛保护的首个人群脑膜炎球菌疫苗已在欧洲获准使用。这种疫苗,即多组份 B 群脑膜炎球菌疫苗(4CMenB),含有重组蛋白和外膜囊泡,已在涉及 7500 多名成人、儿童和婴儿的临床试验中进行了广泛研究。这些试验不仅证明了针对一系列 B 群脑膜炎奈瑟菌菌株的免疫原性,还表明婴儿免疫接种后发热率相对较高。本文将总结该疫苗的组成、临床试验和建议的接种计划,特别关注其免疫原性、反应原性、安全性、潜在覆盖率和最佳实施情况。

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