Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- antibody synthesis induced after Covid-19 vaccination (positive or negative)
研究概览
简要总结
COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.
详细描述
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all in-center haemodialysis individuals eligible and voluntary to receive one of the approved COVID-19 vaccines.
排除标准
- •individuals under 18 years of age
结局指标
主要结局
antibody synthesis induced after Covid-19 vaccination (positive or negative)
时间窗: 1 month after 2nd injection
evaluation of IgG anti-S level
次要结局
- COVID-19 incidence(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- Lack of immunogenicity(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- measure antibody response to vaccines in patient subgroup (diabetic patients, patients with auto-immune disease, patients with cancer, patients with an history of solid organ transplantation)(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- antibody synthesis induced after one injection of Covid-19 vaccine(before second injection)
- Death during follow up(day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months)
- Longevity of the antibody synthesis induced after Covid-19 vaccination(3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection)