中国脑膜炎球菌疫苗发展现状与挑战

徐颖华; 李亚南; 叶强

doi:10.11847/zgggws1136615

中国脑膜炎球菌疫苗发展现状与挑战

doi: 10.11847/zgggws1136615

中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室，北京 102629

基金项目: 国家高技术研究发展计划（863计划）（2012AA02A402）；医学微生物资源子平台运行与服务（NIMR – 2020）

详细信息

作者简介:
徐颖华（1979 – ），男，江西宜黄人，研究员，博士，研究方向：细菌性疫苗质量控制

通讯作者:
叶强，E-mail：qiangyee@nifdc.org.cn

（李亚南为本文并列第一作者）
中图分类号: R 186
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出版历程
- 接收日期: 2021-08-23
- 网络出版日期: 2021-12-30
- 刊出日期: 2022-07-01

Current status and challenges of meningococcal vaccines development in China

Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institute for Food and Drug Control, Beijing 102629, China

摘要

摘要: 接种疫苗是预防流行性脑脊髓膜炎（流脑）最有效、最经济的方法，在过去几十年，随着疫苗的广泛使用，流脑发病率显著下降。目前在中国上市的疫苗主要包括A、C、W、Y群单价和多价多糖脑膜炎球菌疫苗（MPV），A、C群多糖脑膜炎球菌结合疫苗（MPCV-AC）以及A、C群脑膜炎球菌多糖结合b型流感嗜血杆菌结合联合疫苗（MPCV-AC-hib）。纵观我国脑膜炎球菌疫苗近50年的发展历程，在疫苗生产、质量控制以及相关研究方面均取得了显著成绩，但仍然面临着流脑疾病负担被低估、脑膜炎球菌疫苗免疫策略尚未完善、不同厂家脑膜炎球菌疫苗免疫程序不统一、无B群脑膜炎球菌疫苗上市等问题和挑战，为此应不断提高流脑监测手段及系统开展流脑疾病负担评价的研究以助力我国脑膜炎球菌疫苗免疫策略和免疫程序的完善，并针对流脑血清群高度可变和易发生抗原漂移的特性通过基因重组等技术研发出免疫力更长、保护效果更好的可预防所有血清群流脑的通用性疫苗。
- 流行性脑脊髓膜炎（流脑） /
- 脑膜炎球菌疫苗 /
- 发展 /
- 挑战 /
- 中国
Abstract: Vaccination is the most effective and economical way to prevent meningococcal meningitis. In the past few decades, with widespread use of meningococcal vaccines, the incidence of meningococcal meningitis has dropped significantly. There are some vaccines available in Chinese markets, of which mainly included groups A, C, W, and Y monovalent and multivalent polysaccharide meningococcal vaccines (MPV), group A and C polysaccharide meningococcal conjugated vaccines (MPCV-AC), and meningococcal groups A and C and haemophilus b conjugate vaccine (MPCV-AC-hib). With the nearly 50 years of development of meningococcal vaccines in China, significant achievements have been made in vaccine production, quality control, and related research, but the burden of meningococcal disease is still underestimated; the meningococcal vaccine immunization strategy has not been perfected; meningococcal vaccines from different manufacturers have inconsistent immunization procedures and no group B meningococcal vaccines are available in the market. Therefore, it is suggested that meningococcal monitoring methods should be continuously improved and research on meningococcal disease burden should be carried out for facilitating the improvement of meningococcal vaccine immunization procedures and strategy. Furthermore, considering the serogroup highly variable and antigen drift characteristics of Neisseria meningitides, a vaccine with longer immunity and better protection effect should be developed by using genetic recombination and other technologies.
- meningococcal meningitis /
- meningococcal vaccine /
- development /
- challenge /
- China
注释:

1) （李亚南为本文并列第一作者）

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参考文献(30)

[1]	Linder KA, Malani PN. Meningococcal meningitis[J]. JAMA, 2019, 321(10): 1014. doi: 10.1001/jama.2019.0772
[2]	杨俊峰, 李艺星, 尹遵栋, 等. 2004 — 2005年我国流行性脑脊髓膜炎病死率分析[J]. 中国公共卫生, 2006, 22(12): 1518 – 1519. doi: 10.11847/zgggws2006-22-12-65
[3]	Olbrich KJ, Müller D, Schumacher S, et al. Systematic review of invasive meningococcal disease: sequelae and quality of life impact on patients and their caregivers[J]. Infectious Diseases and Therapy, 2018, 7(4): 421 – 438. doi: 10.1007/s40121-018-0213-2
[4]	Xu YH, Li YN, Wang SS, et al. Meningococcal vaccines in China[J]. Human Vaccines and Immunotherapeutics, 2021, 17(7): 2197 – 2204. doi: 10.1080/21645515.2020.1857201
[5]	国家卫生健康委. 2019年全国法定传染病疫情概况[R]. 北京: 国家卫生健康委, 2002.
[6]	国家卫生健康委. 2020年全国法定传染疫情概况[R]. 北京: 国家卫生健康委, 2021.
[7]	Parikh SR, Campbell H, Bettinger JA, et al. The everchanging epidemiology of meningococcal disease worldwide and the poten-tial for prevention through vaccination[J]. Journal of Infection, 2020, 81(4): 483 – 498. doi: 10.1016/j.jinf.2020.05.079
[8]	Pan JR, Yao PP, Zhang H, et al. The case of a new sequence type 7 serogroup X Neisseria meningitidis infection in China: may capsular switching change serogroup profile?[J]. International Journal of Infectious Diseases, 2014, 29: 62 – 64. doi: 10.1016/j.ijid.2014.07.022
[9]	邵祝军, 徐丽, 高源, 等. 中国流行性脑脊髓膜炎流行菌群变化趋势分析[J]. 中国计划免疫, 2007, 13(6): 541 – 544. doi: 10.3969/j.issn.1006-916X.2007.06.008
[10]	Shao ZJ, Li W, Ren J, et al. Identification of a new Neisseria meningitidis serogroup C clone from Anhui province, China[J]. The Lancet, 2006, 367: 419 – 423. doi: 10.1016/S0140-6736(06)68141-5
[11]	李军宏, 吴丹, 温宁, 等. 2015 — 2019年中国流行性脑脊髓膜炎血清群分布特征[J]. 中国疫苗和免疫, 2020, 26(3): 241 – 244.
[12]	赵盼, 朱兵清, 张艾煜, 等. 中国脑膜炎奈瑟菌ST-4821克隆群荚膜基因簇分布特征[J]. 疾病监测, 2020, 35(6): 508 – 512. doi: 10.3784/j.issn.1003-9961.2020.06.011
[13]	国家卫生健康委. 国家卫生健康委关于印发国家免疫规划疫苗儿童免疫程序及说明 (2021年版) 的通知[EB/OL]. (2021 – 03 – 12)[2021 – 08 – 10]. http://www.nhc.gov.cn/jkj/s3581/202103/590a8c7915054aa682a8d2ae8199e222.shtml.
[14]	柴志凯, 李军, 邵祝军, 等. 流行性脑脊髓膜炎监测与免疫预防专家研讨会会议纪要[J]. 中国预防医学杂志, 2015, 16(12): 901 – 903.
[15]	Weintraub A. Immunology of bacterial polysaccharide antigens[J]. Carbohydrate Research, 2003, 338(23): 2539 – 2547. doi: 10.1016/j.carres.2003.07.008
[16]	赵东阳, 谢志强, 苟锦博, 等. 3月龄婴儿接种A群C群脑膜炎球菌多糖结合疫苗的免疫原性和不良反应[J]. 中国疫苗和免疫, 2020, 26(4): 387 – 390.
[17]	国家药品监督管理局. 国产药品数据查询[DB/OL]. 北京: 国家药品监督管理局, (2021 – 08 – 08) [2020 – 08 – 11]. http://app1.nmpa.gov.cn/data_nmpa/face3/base.jsp?tableId=25&tableName=TABLE25&title=%B9%FA%B2%FA%D2%A9%C6%B7&bcId=152904713761213296322795806604&CbSlDlH0=qGk8qacgXhPgXhPgXJnJaEDBV6WPKdJ3CcEJcwU4a_3qqhG.
[18]	Kurosky SK, Davis KL, Krishnarajah G. Effect of combination vaccines on completion and compliance of childhood vaccinations in the United States[J]. Human Vaccines and Immunotherapeutics, 2017, 13(11): 2494 – 2502. doi: 10.1080/21645515.2017.1362515
[19]	Klein NP, Abu-Elyazeed R, Baine Y, et al. Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants[J]. Human Vaccines and Immunotherapeutics, 2019, 15(2): 327 – 338. doi: 10.1080/21645515.2018.1526586
[20]	李亚南, 梁丽, 李艳萍, 等. A、C群脑膜炎球菌 – b型流感嗜血杆菌多糖结合疫苗免疫学效果观察[J]. 中国生物制品学杂志, 2012, 25(9): 1190 – 1194,1197.
[21]	李江嵘, 杨军, 刘晓强, 等. AC群脑膜炎球菌 (结合) b型流感嗜血杆菌 (结合) 联合疫苗上市后2~71月龄儿童接种的安全性研究[J]. 中国疫苗和免疫, 2016, 22(5): 578 – 581.
[22]	Li YX, Yin ZD, Shao ZJ, et al. Population-based surveillance for bacterial meningitis in China, September 2006 – December 2009[J]. Emerging Infectious Diseases, 2014, 20(1): 61 – 69.
[23]	吴丹, 李艺星, 邵祝军, 等. 2006 — 2013年中国4个城市急性脑膜炎脑炎流行病学疾病负担研究[J]. 中华预防医学杂志, 2019, 53(2): 164 – 168.
[24]	邵祝军. 流行性脑脊髓膜炎流行现状及防控形势[J]. 中华预防医学杂志, 2019, 53(2): 129 – 132.
[25]	中华预防医学会. 脑膜炎球菌疫苗的有效性、安全性和成本效益研究进展[J]. 中华流行病学杂志, 2019, 40(2): 129 – 135. doi: 10.3760/cma.j.issn.0254-6450.2019.02.002
[26]	李军宏, 李艺星, 吴丹, 等. 中国2006 — 2014年流行性脑脊髓膜炎病例菌群分布特征及变迁趋势[J]. 中国疫苗和免疫, 2015, 21(5): 481 – 485.
[27]	吴疆. 中国脑膜炎球菌疫苗预防接种专家共识[J]. 中华预防医学杂志, 2019, 53(2): 141 – 145.
[28]	Parikh SR, Newbold L, Slater S, et al. Meningococcal serogroup B strain coverage of the multicomponent 4CMenB vaccine with corresponding regional distribution and clinical characteristics in England, Wales, and Northern Ireland, 2007-08 and 2014-15: a qualitative and quantitative assessment[J]. The Lancet Infectious Diseases, 2017, 17(7): 754 – 762. doi: 10.1016/S1473-3099(17)30170-6
[29]	Ostergaard L, Lucksinger GH, Absalon J, et al. A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults[J]. Vaccine, 2016, 34(12): 1465 – 1471. doi: 10.1016/j.vaccine.2016.01.044
[30]	朱兵清, 高婉迎, 徐丽, 等. 中国B群脑膜炎奈瑟菌分子流行病学特征分析[J]. 中华预防医学杂志, 2019, 53(2): 153 – 158.