[结核疫苗在临床试验中的发展状况]
Eunkyung Shin1, Soo Min Kim1, Jin-Seung Yun1
1질병관리청 국립보건연구원 국립감염병연구소 공공백신개발지원센터 감염병백신연구과.
Jugan geon-gang gwa jilbyeong
|December 3, 2025
概括
15种结核病 (TB) 候选疫苗正在临床试验中,全细胞和重组蛋白质平台正在引领开发. 对新的抗原和模型的进一步研究对于更多样化的结核病疫苗管道至关重要.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 传染病研究 传染病研究
- 临床试验 临床试验
背景情况:
- 结核病 (TB) 仍然是全球主要的死亡原因,其中Bacillus Calmette-Guérin (BCG) 是唯一获得许可的疫苗.
- 开发新的结核病疫苗是全球卫生的一个重大挑战.
研究的目的:
- 提供结核病疫苗临床研究当前情景和未来趋势的概述.
- 确定结核病疫苗候选人在临床开发管道中的状态.
主要方法:
- 在临床开发中对结核病疫苗候选人的文献综述.
- 世界卫生组织 (WHO) 对新疫苗开发报告的分析.
主要成果:
- 截至2024年9月,15种结核病候选疫苗正在临床试验中,包括全细胞,重组蛋白,病毒载体和mRNA平台.
- 两种mRNA疫苗正在第一阶段,M72/AS01E,GemTBvac,MIP,MTBVAC和VPM1002等几种候选疫苗正在第三阶段临床试验中.
- 世界卫生组织预计,在五年内,将会有新的结核病疫苗.
结论:
- 目前的结核病疫苗管道显示平台的多样性,但抗原的潜在冗余性.
- 需要继续研究以确定新型抗原并开发临床前模型以评估疗效.
- 通过临床试验分析确定有效的终点对于推动结核病疫苗开发至关重要.
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