NL-OMON33959已完成不适用
An open phase 1, dose-escalating, clinical trial on the safety of a new liposomal adjuvant system, CAF01, when given with the tuberculosis subunit vaccine Ag85B-ESAT-6 as two injections with two months interval to healthy adult volunteers. - ACAF01-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
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
- •Female and male (18-55 years)
排除标准
- •History of tuberculosis or known exposure
- •Positive Tuberculin Skin Test and/or positive Quantiferon
- •BCG vaccination
- •Thyroid dysfunction
- •Disease affecting the lymphoid organs
- •ANA-titer, HBV, HCV, HIV
- •C-reactive protein level >50 mg/l
- •Live vaccine vaccination within 3 months before the first vaccination
- •Intake of another clinical trial product/vaccine within 3 months from the first vaccination or participation in previous clinical trials with the Ag85B-Esat-6 antigen.
研究者
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