A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Humoral response to vaccination against against SARS-CoV-2 as compared to controls
研究概览
简要总结
This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).
详细描述
Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group.
Study design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine.
Blood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration.
The primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls.
The secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.
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
- •Age of 18 years or older
- •Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine
- •Written informed consent.
排除标准
- •A history of previous COVID-19 disease
- •Active malignancy of any localization
- •Human Immunodeficiency Virus (HIV) infection
- •Maintenance treatment with immunosuppressive therapy.
结局指标
主要结局
Humoral response to vaccination against against SARS-CoV-2 as compared to controls
时间窗: 28 days after the second vaccination
SARS-CoV2 IgG levels
次要结局
- T-cell response against SARS-CoV-2(22 weeks after the second vaccination)
- SARS-CoV-2 incidence(22 weeks after the second vaccination)
- Humoral response to vaccination against against SARS-CoV-2(22 weeks after the second vaccination)
研究者
Ekaterina Parshina
Principal investigator, MD
Saint Petersburg State University, Russia