COVID Vaccine Immunity in Kidney Transplant Recipients
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
- 否
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
Graham C. Towns
Associate Professor
University of Alabama at Birmingham