Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine (ROMANOV)
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.
The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Lyon、法国、69003
- Department of Nephrology, Hopital Edouard Herriot
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Pierre Bénite、法国、69495
- Department of Nephrology, Centre Hospitalier Lyon Sud
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Medical prescription of BTN162b2 mRNA Cov-19 vaccine
- Treatment by chronic (>1 month) haemodialysis
Exclusion Criteria:
- Non-recommended vaccination scheme
- Refusal to consent
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine
Serological response is defined by a 4 fold increase of IgG anti-spike protein of SARS-Cov2 between Day 0 (before vaccination) and after complete vaccination (evaluated at Day 7 - 14 post-boost).
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The immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
大体时间：The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
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IgG anti SARS-Cov2 spike protein will be evaluated by ELISA at Day 0 (at the initiation of vaccination) anti Day 7 - Day 14 after the second dose (peak of response). The seroconversion is defined by an 4 fold increase of IgG anti SARS-Cov2 spike protein titer between Day 0 and Day 7 - Day 14 after second dose. |
The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 69HCL21_0125
- 2021-A00325-36 (其他标识符：ID-RCB)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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