NL-OMON40604已完成3 期
The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies. - Effects of BCG on immune response
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 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
- •- Written informed consent
- •- Age >=18 and <=35 yrs
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)
- •- Disagreement of participant with informing general practitioner of participation in this study
研究者
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