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4CMenB 在预防脑膜炎球菌病方面的成功:来自真实世界经验的证据。

Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience.

机构信息

Paediatric Infectious Diseases Research Group, St. George's University of London, London, UK.

Clinical Infection Unit, St. George's Hospital, London, UK.

出版信息

Arch Dis Child. 2020 Aug;105(8):784-790. doi: 10.1136/archdischild-2019-318047. Epub 2020 Feb 6.

Abstract

Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while survivors are often left with severe long-term sequelae. Young children have the highest incidence of invasive meningococcal disease (IMD), and nearly all cases in the UK, as in most of Europe and many other industrialised countries, are due to group B meningococci (MenB). The licensure of a broad-coverage, recombinant protein-based MenB vaccine (4CMenB) in 2013 was, therefore, heralded a major breakthrough in the fight against IMD. This vaccine was, however, licensed on immunogenicity and reactogenicity studies only, raising uncertainties about field effectiveness, long-term safety and antibody persistence. In 2015, the UK became the first country to implement 4CMenB into the national infant immunisation schedule and, since then, several countries have followed suit. Seven years after licensure, a wealth of real-world data has emerged to confirm 4CMenB effectiveness, along with large-scale safety data, duration of protection in different age groups, successful strategies to reduce vaccine reactogenicity, impact on carriage in adolescents and the potential for 4CMenB to protect against other meningococcal serogroups and against gonorrhoea. A number of questions, however, remain unanswered, including the investigation and management of vaccine-associated fever in infants, as well as disease severity and assessment of breakthrough cases in immunised children. Increasing use of 4CMenB will provide answers in due course. We now have vaccines against all the major serogroups causing IMD worldwide. Next-generation and combination vaccines against multiple serogroups look very promising.

摘要

脑膜炎球菌病仍然是全球最令人恐惧的传染病之一,因为它发病突然、进展迅速、病死率高,而幸存者往往留下严重的长期后遗症。儿童感染侵袭性脑膜炎球菌病(IMD)的发病率最高,而在英国,几乎所有病例,就像在欧洲大部分地区和许多其他工业化国家一样,都是由 B 群脑膜炎球菌(MenB)引起的。2013 年,一种广泛覆盖、基于重组蛋白的 MenB 疫苗(4CMenB)获得许可,这被认为是对抗 IMD 的重大突破。然而,该疫苗仅在免疫原性和反应原性研究中获得许可,这引发了对其现场效果、长期安全性和抗体持久性的不确定。2015 年,英国成为第一个将 4CMenB 纳入国家婴儿免疫计划的国家,此后,许多国家也效仿。许可 7 年后,大量真实世界的数据已经证实了 4CMenB 的有效性,同时还获得了大规模的安全性数据、不同年龄组的保护持续时间、降低疫苗反应原性的成功策略、对青少年带菌的影响以及 4CMenB 预防其他脑膜炎球菌血清群和淋病的潜力。然而,仍有许多问题尚未得到解答,包括婴儿疫苗相关性发热的调查和管理,以及免疫儿童的疾病严重程度和突破病例的评估。随着 4CMenB 的广泛使用,这些问题将在适当的时候得到解答。我们现在已经有了针对全球导致 IMD 的所有主要血清群的疫苗。针对多种血清群的下一代和联合疫苗看起来很有前途。

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