Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
研究概览
简要总结
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.
The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical prescription of BTN162b2 mRNA Cov-19 vaccine
- •Treatment by chronic (>1 month) haemodialysis
排除标准
- •Non-recommended vaccination scheme
- •Refusal to consent
结局指标
主要结局
Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
时间窗: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
IgG anti SARS-Cov2 spike protein will be evaluated by ELISA at Day 0 (at the initiation of vaccination) anti Day 7 - Day 14 after the second dose (peak of response). The seroconversion is defined by an 4 fold increase of IgG anti SARS-Cov2 spike protein titer between Day 0 and Day 7 - Day 14 after second dose.
次要结局
未报告次要终点