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临床试验/NL-OMON40604
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

发起方
niversitair Medisch Centrum Sint Radboud

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