NCT05490342已完成不适用
Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy
University of Rome Tor Vergata1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Rate of positive antibody titer
研究概览
简要总结
To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Liver transplanted patients >18 years of age.
- •Patients who underwent liver transplantation between 01/2015 to 12/
- •Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
- •Patients who have had three doses of a vaccine for the prevention of COVID-
- •Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.
排除标准
- •Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
- •Patients not vaccinated for prevention of SARS-CoV-2 infection.
- •Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.
结局指标
主要结局
Rate of positive antibody titer
时间窗: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
\> 0.8 U/mL
次要结局
- Median antibody titer absolute value(Between 30 and 120 ± 15 days after the completion of the vaccination cycle)
- Rate of highly protective antibody titer(Between 30 and 120 ± 15 days after the completion of the vaccination cycle)
研究者
Tommaso Maria Manzia
Associate Professor
University of Rome Tor Vergata
研究点 (1)
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