针对Mycobacterium结核菌感染和结核病的风险,Bacillus Calmette-Guérin初级疫苗的有效性:对个人参与者数据的元分析
Puck T Pelzer1, Logan Stuck2, Leonardo Martinez3
1Amsterdam University Medical Centres, Amsterdam, Netherlands; KNCV Tuberculosis Foundation, The Hague, Netherlands; London School of Hygiene & Tropical Medicine, London, UK; Department of Global Health and Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands.
巴西勒斯卡尔梅特 - 格林 (BCG) 疫苗显示出对Mycobacterium结核病感染的保护,通过QuantiFERON转换测量,主要是在家庭接触者中. 这一发现可以通过将感染作为早期试验终点来加速结核疫苗的开发.
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:
- 结核病疫苗的开发受到使用疾病作为主要终点的大型,漫长和昂贵的临床试验的阻碍.
- 较早的免疫保护标记可以显著加快开发新的结核病疫苗.
研究的目的:
- 评估Bacillus Calmette-Guérin (BCG) 疫苗在预防Mycobacterium结核病感染方面的有效性是否与其在预防结核病方面的有效性一致.
- 确定免疫学标记物作为结核疫苗试验中替代终点的有用性.
主要方法:
- 对长度研究进行了个人参与者数据 (IPD) 的元分析,报告了BCG疫苗接种,结核菌感染 (QuantiFERON IFN-γ释放试验[IGRA]和结核素皮肤试验[TST]),以及结核病发病率.
- 使用混合效应,多变量比例危险建模来比较BCG对M.结核病感染和疾病的保护效果.
主要成果:
- 在任何研究类型中,BCG接种疫苗都没有证明对TST转换的保护.
- BCG疫苗在家庭接触者中提供了对QuantiFERON转换的保护,与对疾病的保护相一致.
- 在0.7 IU/mL和0.35 IU/mL截止值时观察到对QuantiFERON转换的保护.
结论:
- 根据QuantiFERON转换测量,BCG疫苗对M.结核病感染的保护在不同人群中有所不同.
- 在最近家庭暴露的个体中,QuantiFERON转化可能作为结核疫苗试验中疾病的有效代用终点.
- 结核素皮肤测试 (TST) 在2b期概念验证试验中证明了预防评估的有限价值.
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