Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
时间窗: One month after the 2nd injection of the COVID-19 vaccine
次要结局
- Compare the seroconversion between different vaccines(At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine)
- Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies(At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies)
- Describe the patients characteristics associated with seroconversion(At Month 24 after the 2nd injection of the COVID-19 vaccine)
- Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies(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.)
- Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients(At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection)