DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detection of Cellular-Mediated Immune Response
研究概览
简要总结
In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.
详细描述
First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.
The Investigators will recruit three classes of subjects:
- Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
- Patients with previous Sars-CoV-2 infection who undergone vaccination;
- Subjects without previous Sars-CoV-2 infection who undergone vaccination.
Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.
The Investigators will recruit:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age > 18 years
- •Previous diagnosis of COVID-19
- •Absence of COVID-19 diagnosis
排除标准
- •Age <18 years
- •Inflammatory diseases
结局指标
主要结局
Detection of Cellular-Mediated Immune Response
时间窗: 3 Months
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory
次要结局
- Detection of T cell subpopulation maturation(5 months)
研究者
Giuditta Benincasa
Principal Investigator
University of Campania "Luigi Vanvitelli"