预防Mycobacterium tuberculosis感染的BCG再接种疫苗
Alexander C Schmidt1, Lee Fairlie2, Elizabeth Hellström3
1Gates Medical Research Institute, Cambridge, MA.
The New England journal of medicine
|May 7, 2025
概括
重复接种BCG疫苗并不能预防青少年持续结核病感染. 在2b期试验中,BCG疫苗和安慰剂组之间的QuantiFERON-TB测试转换率没有显著差异.
科学领域:
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
- 疫苗学 疫苗学 疫苗学
背景情况:
- 之前的第二阶段试验表明,细菌卡尔梅特-盖林 (BCG) 重复接种可以预防持续的Mycobacterium结核病感染.
- 持续感染是通过连续阳性QuantiFERON-TB (QFT) 测试来定义的,表明干扰素-玛释放试验转换.
研究的目的:
- 评估BCG再接种与安慰剂在预防持续的M.结核病感染方面的疗效.
- 在青少年BCG再接种疫苗后评估不良事件和免疫性.
主要方法:
- 2b期,双盲,随机,安慰剂对照试验,涉及QFT阴性,HIV阴性青少年.
- 主要终点:防止持续的QFT测试转换.
- 二次分析:不良事件;探索性分析:免疫性.
主要成果:
- 在BCG和安慰剂组之间持续的QFT转换没有显著差异 (危险比:1.04,95%CI:0.73-1.48).
- 疫苗的有效性点估计为-3.8% (95% CI: -48.3-27.4).
- 在BCG组中观察到注射部位反应的增加;BCG诱导的细胞因子阳性1型辅助CD4T细胞.
结论:
- 在研究的青少年群体中,BCG再接种疫苗没有提供对持续的M.结核病感染的保护.
- 可能需要进一步的研究来探索替代性结核病疫苗策略.
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