NL-OMON30684已完成不适用
A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine (Ag85B - ESAT-6 + IC31) administered in PPD positive volunteers at 0 and 2 months - THYB-02
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •BCG-group: BCG-vaccinated > two years before, PPD+ (range 6-15mm) or any documented value between 6-15mm on medical file in the past, with no active, chronic or past TB disease as confirmed by chest X ray, negative Quantiferon-TB gold in Tube test and negative 6-day lymphocyte tests;Infection-group: known to be diagnosed with latent TB, PPD+, previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive Quantiferon-TB Gold In Tube test and or positive 6-day lymphocyte test
- •Healthy based on medical examination/history at the inclusion
- •Age between 18 and 55 ears
- •Signed informed consent
排除标准
- •Granulomatous disease other then TB
- •Vaccinated with live vaccine 3 months before the first vaccination
- •Administration of immune modilating drugs 3 months before first vaccination
- •HBV, HCV, or HIV sero-positive
- •Participation in another clinical trial
- •Known hypersensitivity to any of the vaccine components
- •Laboratory parameters outside of normal range judged by PI to be clinically relevant
- •Pregnant women/planned pregnancy and/or breastfeeding within the trail period
研究者
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