IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 753
- 试验地点
- 1
- 主要终点
- Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
研究概览
简要总结
The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.
详细描述
TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated:
- kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR)
- kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed
The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling.
In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients
- •Recipient age ≥ 18 years
- •Written Informed Consent and Consent for Processing Personal Data
- •Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
排除标准
- •Active SARS-CoV-2 infection.
- •Patients that received anti-SARS-CoV-2 monoclonal antibodies.
- •Active infection after vaccination
- •Monoclonal antibodies treatment ahead of antibody or cellular immunity screening
结局指标
主要结局
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
时间窗: 15 days-90 days
anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination
次要结局
- Clinical variables affecting antibody levels(15 days-90 days)
- The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination(15 days-90 days)
- Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.(3 months - 6 months)
- Graft function after vaccination(15 days-90 days)
- Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.(15 - 90 days)
研究者
Prof. Ondřej Viklický, M.D., Ph.D.
Head of Department of Nephrology and Transplant Center
Institute for Clinical and Experimental Medicine