The Role of Trained Immunity in Fungal Infection and the Mechanism Behind it
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- The level of IL-6
研究概览
简要总结
Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on day 6). On the day 0 (total 20; n = 10 for BCG vaccination, n = 10 for BCG vaccination plus taking metformin), day 14 (total 30; n=15 for BCG vaccination, n = 15 for BCG vaccination plus taking metformin), day 90 (total 26; n = 13 for BCG vaccination, n=13 for BCG vaccination plus taking metformin) of BCG vaccination, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy BCG-naive participants.
- •The ages range from 20 to
- •Participants without any infections or immune deficiencies.
排除标准
- •Participants when infections or other illnesses occurred during the clinical trial.
- •Participants who have a fever of unknown causes during the clinical trial.
- •Participants who have gotten other vaccines during the clinical trial.
研究组 & 干预措施
BCG vaccination with taking metformin on the day 85
干预措施: BCG vaccination (Biological)
BCG vaccination with taking metformin on the day 85
干预措施: Metformin is administered on the day 85 (Drug)
BCG vaccination without metformin
干预措施: BCG vaccination (Biological)
Placebo
干预措施: Placebo (Other)
BCG vaccination with taking metformin on the day 0
干预措施: BCG vaccination (Biological)
BCG vaccination with taking metformin on the day 0
干预措施: Metformin is administered on the day 0 (Drug)
BCG vaccination with taking metformin on the day 9
干预措施: BCG vaccination (Biological)
BCG vaccination with taking metformin on the day 9
干预措施: Metformin is administered on the day 9 (Drug)
结局指标
主要结局
The level of IL-6
时间窗: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.
The level of TGF-alpha
时间窗: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.
次要结局
未报告次要终点
研究者
Zhibing Lu
Professor
Zhongnan Hospital