Spike-specific Cellular Immune Response After COVID-19 Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- measurement of cellular response
研究概览
简要总结
Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.
To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.
Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.
详细描述
After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.
All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.
Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.
Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.
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
- 是
入选标准
- •vaccinated and non vaccinated subjects
- •subjects that never tested positive for COVID19
排除标准
- •subjects that tested positive for COVID-19
结局指标
主要结局
measurement of cellular response
时间窗: 7 months
evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination
次要结局
未报告次要终点