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开发MenFive®,一种面向非洲及其他地区的价格亲民的五价脑膜炎球菌结合疫苗(ACYWX)。

Development of MenFive®, an affordable pentavalent meningococcal conjugate vaccine (ACYWX) for Africa and beyond.

作者信息

Alderson Mark R, Regan Katie, Martellet Lionel, Hosken Nancy, Kulkarni Prasad S, Pisal Sambhaji S, LaForce F Marc, Dhere Rajeev M

机构信息

Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.

Center for Vaccine innovation and Access, PATH, Geneva, Switzerland.

出版信息

Hum Vaccin Immunother. 2025 Dec;21(1):2559506. doi: 10.1080/21645515.2025.2559506. Epub 2025 Sep 18.

DOI:10.1080/21645515.2025.2559506
PMID:40968077
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12452429/
Abstract

Wide use of the groundbreaking vaccine MenAfriVac® has eliminated serogroup A meningococcal meningitis in the African meningitis belt and paved the way for elimination of all meningococcal disease outbreaks with the development, licensure, and introduction of an affordable multivalent conjugate vaccine that covers all disease-causing serogroups in the region. With supportive funding from the UK government's Foreign, Commonwealth & Development Office, the global public health nonprofit PATH, and the Serum Institute of India Pvt. Ltd. extended their collaboration on MenAfriVac to develop, license, and World Health Organization prequalify MenFive®, an ACWYX meningococcal conjugate vaccine. The task of developing a low-priced, strongly immunogenic, pentavalent meningococcal conjugate vaccine required multiple collaborators and complex coordination, with numerous challenges and lessons learned. Importantly, MenFive has the potential to eliminate meningococcal disease outbreaks-not only in Africa (with recent deployment of outbreak response during the 2024 and 2025 meningitis seasons) but also in other regions of the world.

摘要

突破性疫苗MenAfriVac®的广泛使用已在非洲脑膜炎带消除了A群脑膜炎球菌性脑膜炎,并为通过研发、许可和引入一种可负担得起的多价结合疫苗来消除所有脑膜炎球菌病疫情铺平了道路,该疫苗覆盖该地区所有致病血清群。在英国政府外交、联邦及发展办公室、全球公共卫生非营利组织PATH以及印度血清研究所私人有限公司的支持性资助下,他们将在MenAfriVac方面的合作扩展至研发、许可并使世界卫生组织对ACWYX脑膜炎球菌结合疫苗MenFive®进行预认证。开发一种低价、强免疫原性的五价脑膜炎球菌结合疫苗的任务需要多个合作伙伴以及复杂的协调工作,期间面临诸多挑战并积累了不少经验教训。重要的是,MenFive不仅有潜力在非洲消除脑膜炎球菌病疫情(近期在2024年和2025年脑膜炎季节已部署疫情应对措施),而且在世界其他地区也有此潜力。

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Hum Vaccin Immunother. 2025 Dec;21(1):2559506. doi: 10.1080/21645515.2025.2559506. Epub 2025 Sep 18.
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本文引用的文献

1
Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when co-administered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial.在马里,9月龄和15月龄儿童五价脑膜炎球菌结合疫苗(针对A、C、W、Y和X血清群)与常规儿童疫苗同时接种时的安全性和免疫原性:一项单中心、双盲、随机、对照、3期、非劣效性试验。
Lancet. 2025 Mar 29;405(10484):1069-1080. doi: 10.1016/S0140-6736(25)00046-7. Epub 2025 Mar 11.
2
Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study.在印度成年人中,五价脑膜炎球菌结合疫苗与四价脑膜炎球菌结合疫苗的安全性和免疫原性:一项观察者盲法、随机、活性对照、2/3期研究。
Lancet Infect Dis. 2025 Apr;25(4):399-410. doi: 10.1016/S1473-3099(24)00576-0. Epub 2024 Nov 6.
3
Strengthening and expanding capacities in clinical trials: advancing pandemic prevention, preparedness and response in Africa.加强和扩大临床试验能力:推进非洲大流行病的预防、防备和应对。
Nat Commun. 2024 Oct 7;15(1):8662. doi: 10.1038/s41467-024-53126-3.
4
The meningitis outbreak returns to Niger: Concern, efforts, challenges, and recommendations.脑膜炎疫情在尼日尔卷土重来:关注、努力、挑战和建议。
Immun Inflamm Dis. 2023 Jul;11(7):e953. doi: 10.1002/iid3.953.
5
Global, regional, and national burden of meningitis and its aetiologies, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.全球、区域和国家的脑膜炎及其病因负担,1990-2019 年:全球疾病负担研究 2019 年的系统分析。
Lancet Neurol. 2023 Aug;22(8):685-711. doi: 10.1016/S1474-4422(23)00195-3.
6
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7
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BMC Infect Dis. 2023 Apr 6;23(1):202. doi: 10.1186/s12879-023-08196-x.
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Vaccine. 2022 Oct 6;40(42):6042-6047. doi: 10.1016/j.vaccine.2022.08.013. Epub 2022 Sep 8.
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BMC Infect Dis. 2021 Sep 30;21(1):1027. doi: 10.1186/s12879-021-06724-1.
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Pathogens. 2021 Jul 23;10(8):928. doi: 10.3390/pathogens10080928.