Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neutralizing antibody titer change 14 days after vaccination compared to baseline
研究概览
简要总结
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.
详细描述
fifty living donor liver transplantation recipients during maintenance immunosuppression phase will be vaccinated against COVID-19 followed by assessment of immune response to the vaccine and further investigation of correlation of immune response to genetic polymorphisms of HLA DRB1(rs2647087) gene and IL-18 (rs187238 and rs917997) gene.
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
- •At least 3 month post transplantation
排除标准
- •pediatric recipients
- •Active covid infection at the time of the study
- •Pregnancy
- •Allergy to any ingredients included in the vaccine
- •Lactation in first six month of delivery
- •Active Acute cellular rejection proven by liver biopsy
- •Acute Febrile state with either leucopenia or leucocytosis
- •High dose of corticosteroid at study timing (pulse methyl prednisolone)
结局指标
主要结局
Neutralizing antibody titer change 14 days after vaccination compared to baseline
时间窗: At baseline, at 14 days after whole course of vaccination
neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
Neutralizing antibody titer change 28 days post vaccination compared to baseline
时间窗: At baseline and 28 days after whole course of vaccination
neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
次要结局
- Interleukin-6 serum level(At baseline, at 14 and 28 days after whole course of vaccination)
- Incidence of confirmed coronavirus disease(28 days after whole course of vaccination)
- Incidence of adverse events related to vaccine(7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered)
- Incidence of acute graft rejection(On 14 and 28 days post whole course vaccination)
- Immune response correlation to IL-18 genetic polymorphism(28 days post whole course vaccination)
- Immune response correlation to HLA DRB1 genetic polymorphism(28 days post whole course vaccination)
研究者
Rana Sayed Fouad
Principal investigator
Ain Shams University