结核病疫苗免疫策略研究进展

doi:10.19982/j.issn.1000-6621.20250008

摘要/Abstract

摘要：

结核病是全球重要的公共卫生问题,卡介苗(BCG)虽可有效预防儿童重症结核病,但对青少年和成人等结核病高风险人群的保护效果有限,无法有效降低全球结核病疾病负担。本文分别从BCG免疫策略优化(包括BCG接种途径和BCG再接种)和新型疫苗研发(包括BCG取代疫苗、BCG加强疫苗和治疗性疫苗)两个方面,总结了全球结核病疫苗免疫策略研究进展,分析了不同策略特点及挑战,为结核病防控工作提供参考依据。

关键词: 结核, 疫苗, 卡介苗, 总结性报告(主题)

Abstract:

Tuberculosis (TB) remains a critical global public health threat. While Bacille Calmette-Guérin (BCG) vaccination provides substantial protection against severe TB in children, it offers limited efficacy in high-risk populations such as adolescents and adults, and fails to significantly reduce the overall global TB burden. This review highlights two primary domains in TB vaccine immunization strategies: optimization of BCG-based approaches—including vaccination route modifications and revaccination—and the development of next-generation vaccines, encompassing BCG replacement, BCG booster, and therapeutic candidates. It synthesizes recent global progress in TB vaccine research, critically evaluates the distinct features and limitations of each strategy, and offers evidence-based perspectives to support future TB prevention and control efforts.

Key words: Tuberculosis, Vaccines, BCG vaccine, Consensus development conferences as topic

中图分类号:

于慧敏, 郑徽, 刘二勇, 黄飞, 吴丹, 尹遵栋. 结核病疫苗免疫策略研究进展[J]. 中国防痨杂志, 2025, 47(7): 930-939. doi: 10.19982/j.issn.1000-6621.20250008

Yu Huimin, Zheng Hui, Liu Eryong, Huang Fei, Wu Dan, Yin Zundong. Research progress on immunization strategies for tuberculosis vaccines[J]. Chinese Journal of Antituberculosis, 2025, 47(7): 930-939. doi: 10.19982/j.issn.1000-6621.20250008

图/表 1

表1

目前处于临床试验阶段的部分结核病疫苗情况

疫苗	研发机构	国家	种类	功能	接种方式	人群	临床试验阶段
Ad5Ag85A	麦克马斯特大学、康希诺	加拿大	病毒载体疫苗	卡介苗加强免疫	肌肉、气雾剂吸入	成人	Ⅰ期
TB/FLU-05E	斯莫罗金采夫流感研究所	俄罗斯	病毒载体疫苗	卡介苗加强免疫	鼻内	成人	Ⅰ期
BNT164a1和 BNT164b1	Biontech	德国	mRNA 疫苗	卡介苗加强免疫	肌肉	成人	Ⅰ期
AEC/BC02	安徽智飞龙科马生物制药公司	中国	亚单位疫苗	预防结核分枝杆菌潜伏感染发展为活动性结核病	肌肉	成人	Ⅱa期
ID93/GLA-SE	Quratis、美国国立卫生研究院、美国国际过敏和传染病研究所	韩国、美国	亚单位疫苗	卡介苗加强免疫、预防结核分枝杆菌潜伏感染发展为活动性结核病、辅助治疗结核病、预防结核病复发	肌肉	青少年、成人	Ⅱa期
ChAdOx1.85A	牛津大学	英国	病毒载体疫苗	卡介苗加强免疫	肌肉、气雾剂吸入	青少年、成人	Ⅱb期
MVA85A	牛津大学	英国	病毒载体疫苗	卡介苗加强免疫	皮内、肌肉、气雾剂吸入	婴儿、儿童、青少年、成人	Ⅱb期
DAR-901	达特茅斯学院、圣路易斯大学	美国	分枝杆菌灭活疫苗	卡介苗加强免疫	皮内	青少年、成人	Ⅱb期
RUTI	Archivel Farma, S.L.	西班牙	分枝杆菌灭活疫苗	预防结核分枝杆菌潜伏感染发展为活动性结核病	皮下、肌肉	成人	Ⅱb期
H56∶IC31	丹麦国立血清研究所、Valneva、IAVI	丹麦	亚单位疫苗	卡介苗加强免疫、辅助治疗结核病、预防结核病复发	肌肉	青少年、成人	Ⅱb期
MTBVAC	萨拉戈萨大学、Biofabri、IAVI、TBVI	西班牙、美国	减毒活疫苗	基础免疫、卡介苗加强免疫	皮内	婴儿、青少年、成人	Ⅲ期
VPM1002	SIIPL、VPM	印度、德国	重组卡介苗	基础免疫、预防结核病复发	皮内	婴儿、儿童、青少年、成人	Ⅲ期
MIP/Immuvac	印度医学研究理事会、Cadila Pharmaceuticals	印度	分枝杆菌灭活疫苗	辅助治疗结核病	皮内	成人	Ⅲ期
GamTBvac	俄罗斯卫生部	俄罗斯	亚单位疫苗	卡介苗加强免疫	皮下	成人	Ⅲ期
M72/AS01E	GSK、比尔及梅琳达·盖茨医学研究所	英国、美国	亚单位疫苗	预防结核分枝杆菌潜伏感染发展为活动性结核病	肌肉	儿童、青少年、成人	Ⅲ期

表1

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