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临床试验/NCT05387343
NCT05387343撤回不适用

COVID Vaccine Immunity in Kidney Transplant Recipients

University of Alabama at Birmingham0 个研究点开始时间: 2022年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
COVID spike protein IgG and Tcell assay

研究概览

简要总结

50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

详细描述

50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
  • no prior transplant
  • no known history of COVID infection
  • had at least 2 doses of mRNA COVID vaccine
  • undergoing transplantation at the University of Alabama at Birmingham
  • multi-organ transplant allowed

排除标准

  • active COVID infection
  • participant is not vaccinated against COVID

结局指标

主要结局

COVID spike protein IgG and Tcell assay

时间窗: month 12

transplant patient response to vaccine compared to response of patients not on immunosuppression

COVID spike protein Immunoglobulin G (IgG) and Tcell assay

时间窗: pre-transplant

transplant patient response to vaccine compared to response of patients not on immunosuppression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Graham C. Towns

Associate Professor

University of Alabama at Birmingham

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