EUCTR2021-000412-28-BE进行中（未招募）1 期
COVID-19: Sars-Cov2 vaccination in kidney transplant patient: a phase IV study of the immunogenicity and its determinants - NEPHRO-VAC transplantation
Hopital Erasme, Université Libre de Bruxelles0 个研究点目标入组 80 人开始时间: 2021年2月4日最近更新:
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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
- 80
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
- All
入选标准
- •- Age of 18 years old or older
- •- Patients should met one of the cohort criteria
- •- life expectancy > 12 months
- •- Ability to provide informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- women who are pregnant or breastfeeding.
- •To reflect the real-world population of kidney transplant patients, the NEPHRO-VAC transplantation project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective. Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.
研究者
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