EUCTR2013-005520-42-NL进行中（未招募）1 期
The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers - Effects of BCG on immune response
Radboud University Nijmegen Medical Centre0 个研究点目标入组 36 人开始时间: 2014年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Written informed consent
- •- Age =18 and =35 yrs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Use of any medication
- •- History of BCG-vaccination
- •- Vaccination other than BCG, within 3 months prior to study or within study period
- •- Previous spontaneous vagal collapse
- •- History of atrial or ventricular arrhythmia
- •- (Family) history of myocardial infarction or stroke under the age of 65 years
- •- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
- •- Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
- •- Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- •- Renal impairment (defined as plasma creatinin >120 µmol/l)
- •- Liver enzyme abnormalities or positive hepatitis serology
- •- Medical history of any disease associated with immune deficiency
- •- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxin administration
- •- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge
- •- Use of recreational drugs within 21 days prior to experiment day
- •- Recent hospital admission or surgery with general anaesthesia (<3 months)
研究者
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