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4CMenB 的十年历程及未来展望。

4CMenB journey to the 10-year anniversary and beyond.

机构信息

GSK, Rueil-Malmaison, France.

Genetics, Vaccines and Infections Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago and Universidad de, Santiago de Compostela, Spain.

出版信息

Hum Vaccin Immunother. 2024 Dec 31;20(1):2357924. doi: 10.1080/21645515.2024.2357924. Epub 2024 Jul 8.

Abstract

The 4-component meningococcal serogroup B (MenB) vaccine, 4CMenB, the first broadly protective, protein-based MenB vaccine to be licensed, is now registered in more than 50 countries worldwide. Real-world evidence (RWE) from the last decade confirms its effectiveness and impact, with infant immunization programs showing vaccine effectiveness of 71-95% against invasive MenB disease and cross-protection against non-B serogroups, including a 69% decrease in serogroup W cases in 4CMenB-eligible cohorts in England. RWE from different countries also demonstrates the potential for additional moderate protection against gonorrhea in adolescents. The real-world safety profile of 4CMenB is consistent with prelicensure reports. Use of the endogenous complement human serum bactericidal antibody (enc-hSBA) assay against 110 MenB strains may enable assessment of the immunological effectiveness of multicomponent MenB vaccines in clinical trial settings. Equitable access to 4CMenB vaccination is required to better protect all age groups, including older adults, and vulnerable groups through comprehensive immunization policies.

摘要

四价脑膜炎奈瑟菌 B 型(MenB)疫苗 4CMenB 是首个获得许可的广泛保护、基于蛋白的 MenB 疫苗,目前已在全球 50 多个国家注册。过去十年的真实世界证据(RWE)证实了其有效性和影响,婴幼儿免疫计划显示疫苗对侵袭性 MenB 疾病的有效性为 71%-95%,并对非 B 血清群具有交叉保护作用,包括在英格兰,4CMenB 适用人群中血清群 W 病例减少了 69%。来自不同国家的 RWE 还表明,青少年中针对淋病的额外中度保护作用具有一定潜力。4CMenB 的真实世界安全性与上市前报告一致。使用针对 110 株脑膜炎奈瑟菌的内源性补体人血清杀菌抗体(enc-hSBA)检测可能有助于评估临床试验环境中多种成分 MenB 疫苗的免疫效力。需要公平获得 4CMenB 疫苗接种,以通过全面免疫政策更好地保护所有年龄段,包括老年人和弱势群体。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab57/11232649/e871dac2bdc6/KHVI_A_2357924_UF0001_OC.jpg

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