Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Neutralizing antibodies against SARS-CoV-2
研究概览
简要总结
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
详细描述
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health. Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
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
- •Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
- •Age ≥ 18 years old
排除标准
- •Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
结局指标
主要结局
Neutralizing antibodies against SARS-CoV-2
时间窗: Day 50 (28 days after the second dose of the vaccine)
Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations
次要结局
- Number of memory B-cells against SARS-CoV-2(Month 18)
- Neutralizing antibodies against SARS-CoV-2(Month 18)
- Development of anti-S-RBD antibodies against SARS-CoV-2(Month 18)
- Number of monocytes (CD14+, CD16+)(Month 18)
- CRP levels(Month 18)
- Number of memory T-cells against SARS-CoV-2(Month 18)
- Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels(Month 18)
- TNF-a levels(Month 18)
研究者
Prof Evangelos Terpos
Professor of Therapeutics-Hematology
National and Kapodistrian University of Athens