Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients (COVATRANS)
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.
It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.
Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Strasbourg、法国、67000
- 招聘中
- Hôpitaux Universitaires de Strasbourg
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接触：
- Sophie Ohlmann, MD
- 电话号码：33 0369551320
- 邮箱：sophie.ohlmann@chru-strasbourg.fr
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
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:
- Patient, male or female, adult or child (15 years and older)
- Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
- Solid organ transplant recipient
- Transplantation for more than 3 months
Exclusion Criteria:
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months preceding inclusion
- Formal contraindication to an intra-muscular injection
- Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
- Subject under legal protection
- Subject under guardianship or curatorship
- Patient having expressed his opposition to participate
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 |
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Kidney transplant recipients who receive Covid-19 vaccine
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
大体时间：One month after the 2nd injection of the COVID-19 vaccine
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One month after the 2nd injection of the COVID-19 vaccine
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次要结果测量
结果测量 |
大体时间 |
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Compare the seroconversion between different vaccines
大体时间：At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
大体时间：At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
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At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
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Describe the patients characteristics associated with seroconversion
大体时间：At Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 24 after the 2nd injection of the COVID-19 vaccine
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Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
大体时间：At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
大体时间：At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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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 (预期的)
研究完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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