《世界卫生组织新型结核病疫苗首选产品特性》的解读与思考

doi:10.19982/j.issn.1000-6621.20230318

中国防痨杂志 ›› 2023, Vol. 45 ›› Issue (11): 1016-1020.doi: 10.19982/j.issn.1000-6621.20230318

《世界卫生组织新型结核病疫苗首选产品特性》的解读与思考

董佳欣¹^,², 赵爱华², 夏焕章¹(), 徐苗²()

¹沈阳药科大学生命科学与生物制药学院,沈阳 110016
²中国食品药品检定研究院生物制品检定所,北京 102629

收稿日期:2023-09-04 出版日期:2023-11-10 发布日期:2023-11-03
通信作者: 徐苗,Email:xumiaobj@126.com;夏焕章,Email:xiahz612@sina.com
基金资助:
耐药结核菌对疫苗及药物有效性影响的体内评价体系(2021YFC230170302)

Interpretation and reflection on the WHO Preferred Product Characteristics for New Tuberculosis Vaccines

Dong Jiaxin¹^,², Zhao Aihua², Xia Huanzhang¹(), Xu Miao²()

¹School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang 110016, China
²Institute of Biological Product Control, National Institutes for Food and Drug Control, Beijing 102629, China

Received:2023-09-04 Online:2023-11-10 Published:2023-11-03
Contact: Xu Miao, Email: xumiaobj@126.com; Xia Huanzhang, Email: xiahz612@sina.com
Supported by:
In vivo Evaluation System for the Effect of Drug-resistant TB on the Effectiveness of Vaccines and Drugs(2021YFC230170302)

摘要/Abstract

摘要：

尽管全球研究进展与日俱进,但至今仍未有新型结核病疫苗成功上市。为终止结核病流行,亟需开发新的结核病疫苗,世界卫生组织(World Health Organization,WHO)于2018年发布了WHO Preferred Product Characteristics for New Tuberculosis Vaccines。该文件介绍了WHO对新型结核病疫苗的偏好。笔者对该文件进行解读,分析结核病新疫苗的发展方向,希望能为疫苗研究者提供开发思路,开发出更符合实际需求的结核病新疫苗。

关键词: 分枝杆菌,结核, 感染, 疫苗

Abstract:

Despite significant advancements in global research, no new tuberculosis (TB) vaccine has been successfully licensed so far. Development of new TB vaccines is urgently needed to end the prevalence of TB, therefore, the World Health Organization (WHO) published the report “WHO Preferred Product Characteristics for New Tuberculosis Vaccines” in 2018. This document outlines the preferences of WHO for new TB vaccines. The authors interpret the document and analyze the direction of development for new TB vaccines, in hope to provide valuable insights for vaccine researchers and formulate new TB vaccines more adaptable to practical needs.

Key words: Mycobacterium tuberculosis, Infection, Vaccines

中图分类号:

R52
R186

董佳欣, 赵爱华, 夏焕章, 徐苗. 《世界卫生组织新型结核病疫苗首选产品特性》的解读与思考[J]. 中国防痨杂志, 2023, 45(11): 1016-1020. doi: 10.19982/j.issn.1000-6621.20230318

Dong Jiaxin, Zhao Aihua, Xia Huanzhang, Xu Miao. Interpretation and reflection on the WHO Preferred Product Characteristics for New Tuberculosis Vaccines[J]. Chinese Journal of Antituberculosis, 2023, 45(11): 1016-1020. doi: 10.19982/j.issn.1000-6621.20230318

参考文献 26

[1]	蒋加庆, 景辉. 卡介苗生产工艺、质量、使用现状及新型结核病疫苗的发展趋势. 中国生物制品学杂志, 2021, 34(10): 1260-1268. doi:10.13200/j.cnki.cjb.003459.
[2]	World Health Organization. WHO preferred product characteristics for new tuberculosis vaccines. Gevena: World Health Organization, 2018.
[3]	Aagaard C, Hoang T, Dietrich J, et al. A multistage tuberculosis vaccine that confers efficient protection before and after exposure. Nat Med, 2011, 17(2):189-194. doi:10.1038/nm.2285. pmid: 21258338
[4]	Lin PL, Dietrich J, Tan E, et al. The multistage vaccine H 56 boosts the effects of BCG to protect cynomolgus macaques against active tuberculosis and reactivation of latent Mycobacterium tuberculosis infection. J Clin Invest, 2012, 122(1):303-314. doi:10.1172/JCI46252.
[5]	Billeskov R, Lindenstrøm T, Woodworth J, et al. High Antigen Dose Is Detrimental to Post-Exposure Vaccine Protection against Tuberculosis. Front Immunol, 2018, 8:1973. doi:10.3389/fimmu.2017.01973.
[6]	Hoang T, Aagaard C, Dietrich J, et al. ESAT-6 (EsxA) and TB10.4 (EsxH) based vaccines for pre- and post-exposure tuberculosis vaccination. PLoS One, 2013, 8(12): e80579. doi:10.1371/journal.pone.0080579.
[7]	Lin PL, Ford CB, Coleman MT, et al. Sterilization of granulomas is common in active and latent tuberculosis despite within-host variability in bacterial killing. Nat Med, 2014, 20(1):75-79. doi:10.1038/nm.3412. pmid: 24336248
[8]	Lawal IO, Abubakar S, Ankrah AO, et al. Molecular Imaging of Tuberculosis. Semin Nucl Med, 2023, 53(1):37-56. doi:10.1053/j.semnuclmed.2022.07.001.
[9]	Minassian AM, Satti I, Poulton ID, et al. A human challenge model for Mycobacterium tuberculosis using Mycobacterium bovis bacille Calmette-Guerin. J Infect Dis, 2012, 205(7):1035-1042. doi:10.1093/infdis/jis012. pmid: 22396610
[10]	Harris SA, Meyer J, Satti I, et al. Evaluation of a human BCG challenge model to assess antimycobacterial immunity induced by BCG and a candidate tuberculosis vaccine, MVA85A, alone and in combination. J Infect Dis, 2014, 209(8):1259-1268. doi:10.1093/infdis/jit647. pmid: 24273174
[11]	Minhinnick A, Harris S, Wilkie M, et al. Optimization of a Human Bacille Calmette-Guérin Challenge Model: A Tool to Evaluate Antimycobacterial Immunity. J Infect Dis, 2016, 213(5):824-830. doi:10.1093/infdis/jiv482. pmid: 26450421
[12]	Lu JB, Chen BW, Wang GZ, et al. Recombinant tuberculosis vaccine AEC/BC 02 induces antigen-specific cellular responses in mice and protects guinea pigs in a model of latent infection. J Microbiol Immunol Infect, 2015, 48(6):597-603. doi:10.1016/j.jmii.2014.03.005.
[13]	Guo X, Lu J, Li J, et al. The Subunit AEC/BC 02 Vaccine Combined with Antibiotics Provides Protection in Mycobacterium tuberculosis-Infected Guinea Pigs. Vaccines (Basel), 2022, 10(12):2164. doi:10.3390/vaccines10122164.
[14]	Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill, 2013, 18(16):20455.
[15]	Tait DR, Hatherill M, Van Der Meeren O, et al. Final Analysis of a Trial of M72/AS01_E Vaccine to Prevent Tuberculosis. N Engl J Med, 2019, 381(25):2429-2439. doi:10.1056/NEJMoa1909953.
[16]	Roordink D, Williams A, Fritzell B, et al. The TB vaccine development pathway-An innovative approach to accelerating global TB vaccine development. Tuberculosis (Edinb), 2021, 126:102040. doi:10.1016/j.tube.2020.102040.
[17]	Nemes E, Geldenhuys H, Rozot V, et al. Prevention of M.tuberculosis Infection with H4:IC 31 Vaccine or BCG Revaccination. N Engl J Med, 2018, 379(2):138-149. doi:10.1056/NEJMoa1714021.
[18]	Luabeya AK, Kagina BM, Tameris MD, et al. First-in-human trial of the post-exposure tuberculosis vaccine H56:IC 31 in Mycobacterium tuberculosis infected and non-infected healthy adults. Vaccine, 2015, 33(33):4130-4140. doi:10.1016/j.vaccine.2015.06.051.
[19]	Suliman S, Luabeya AKK, Geldenhuys H, et al. Dose Optimization of H56:IC 31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial. Am J Respir Crit Care Med, 2019, 199(2):220-231. doi:10.1164/rccm.201802-0366OC.
[20]	中国防痨协会, 中国防痨协会学校与儿童结核病防治专业分会, 《中国防痨杂志》编辑委员会. 重组结核杆菌融合蛋白(EC)临床应用专家共识. 中国防痨杂志, 2020, 42(8):761-768. doi:10.3969/i.issn.1000-6621.2020.08.001.
[21]	Xia L, Xu M, Li F, et al. High accuracy of recombinant fusion protein early secretory antigenic target protein 6-culture filtrate protein 10 skin test for the detection of tuberculosis infection: a phase Ⅲ, multi-centered, double-blind, hospital-based, randomized controlled trial. Int J Infect Dis, 2023, 126:98-103. doi:10.1016/j.ijid.2022.11.014.
[22]	陈柠, 孙琳, 申阿东, 等. 卡介苗接种后发生感染的可能原因研究现况. 中国防痨杂志, 2020, 42(8):869-873. doi:10.3969/j.issn.1000-6621.2020.08.017.
[23]	Cobelens F, Suri RK, Helinski M, et al. Accelerating research and development of new vaccines against tuberculosis: a global roadmap. Lancet Infect Dis, 2022, 22(4): e108-e120. doi:10.1016/S1473-3099(21)00810-0.
[24]	The European and Developing Countries Clinical Trials Partnership. EDCTP and AIGHD launched a global roadmap for tuberculosis vaccine development[EB/OL].[2023-07-10]. http://www.edctp.org/news/edctp-and-aighd-launched-a-global-roadmap-for-tuberculosis-vaccine-development/#.
[25]	Clark RA, Mukandavire C, Portnoy A, et al. The impact of alternative delivery strategies for novel tuberculosis vaccines in low-income and middle-income countries: a modelling study. Lancet Glob Health, 2023, 11(4): e546-e555. doi:10.1016/S2214-109X(23)00045-1.
[26]	卢锦标, 徐苗. 结核灭活疫苗的临床研究进展. 微生物学免疫学进展, 2019, 47(4):69-74. doi:10.1016/S2214-109X(23)00045-1.

《世界卫生组织新型结核病疫苗首选产品特性》的解读与思考

Interpretation and reflection on the WHO Preferred Product Characteristics for New Tuberculosis Vaccines

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献 26

相关文章 15

编辑推荐

Metrics

本文评价

友情链接

[1]	杜毓, 张海鹏, 王鹏. 分枝杆菌噬菌体的研究现状及应用进展[J]. 中国防痨杂志, 2023, 45(9): 897-903.
[2]	毕秀丽, 耿红, 金瑾. 髓系细胞和CD4⁺ T细胞在结核分枝杆菌感染和免疫病理中的作用[J]. 中国防痨杂志, 2023, 45(9): 904-912.
[3]	郭同磊, 辛赫男, 高磊. 《世界卫生组织结核病整合指南模块1:结核病预防性治疗》解读[J]. 中国防痨杂志, 2023, 45(8): 723-727.
[4]	汪敏, 袁园, 谭守勇, 杨子龙, 冯治宇, 张宏, 吴迪, 陈泽莹, 黄显林, 邝浩斌. 2型糖尿病合并初治菌阳肺结核患者肺部广泛病灶和空洞发生的危险因素分析[J]. 中国防痨杂志, 2023, 45(8): 761-767.
[5]	王庆, 丁彩红, 高绪胜, 解丹, 蒋培培, 熊瑜. 含贝达喹啉方案治疗非结核分枝杆菌病三例[J]. 中国防痨杂志, 2023, 45(8): 814-817.
[6]	辛赫男, 高磊. 《世界卫生组织结核病整合指南模块3:诊断——结核感染检测》解读[J]. 中国防痨杂志, 2023, 45(7): 639-643.
[7]	李艳阳, 陈华, 陈品儒. 慢生黄分枝杆菌肺病一例[J]. 中国防痨杂志, 2023, 45(7): 714-717.
[8]	中国人民解放军总医院第八医学中心结核病医学部, 《中国防痨杂志》编辑委员会, 中国医疗保健国际交流促进会结核病防治分会. 核酸基质辅助激光解吸电离飞行时间质谱技术在结核病和非结核分枝杆菌病诊断中的临床应用专家共识[J]. 中国防痨杂志, 2023, 45(6): 543-558.
[9]	董静, 史雨婷, 潘丽萍, 张宗德. 长链非编码RNA抗结核分枝杆菌感染功能的研究进展[J]. 中国防痨杂志, 2023, 45(6): 613-619.
[10]	王大宽, 张彬, 刘自森, 段伟焘, 高磊. 基层结核病预防性治疗门诊建设的探索与展望[J]. 中国防痨杂志, 2023, 45(5): 442-445.
[11]	李姗姗, 王玉峰, 舒薇, 逄宇. 结核病实验室诊断技术研发新进展[J]. 中国防痨杂志, 2023, 45(5): 446-453.
[12]	岳永宁, 范大鹏, 商学钗, 李浩, 李奂谕, 周锦阳, 蔡龙. BS-400全自动分枝杆菌液体培养系统对分枝杆菌培养的效果评价[J]. 中国防痨杂志, 2023, 45(5): 483-487.
[13]	段鸿飞. 及时掌握研究进展切实提高非结核分枝杆菌病治疗水平[J]. 中国防痨杂志, 2023, 45(4): 329-332.
[14]	赵爱华, 都伟欣, 王国治, 徐苗. 重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨[J]. 中国防痨杂志, 2023, 45(4): 333-335.
[15]	鲍生娟, 邵玲玲, 王敬, 韩喜琴, 黄海荣, 段鸿飞. 脓肿分枝杆菌脓肿亚种肺病6个月治疗效果及影响因素分析[J]. 中国防痨杂志, 2023, 45(4): 349-354.