The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,868
- 试验地点
- 1
- 主要终点
- The incidence of COVID-19
研究概览
简要总结
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination.
Study design: prospective single center observational cohort study.
Study population:
- all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE)
- all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR).
- All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals.
Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5. Patients who will undergo a 3rd SARS-CoV-2 vaccination via the national vaccination program for immunocompromised patients will be asked to carry out the mailer-based finger-prick 28 days after the 3rd SARS-CoV-2 vaccination, instead of the antibody measurement 6 months after the 2nd SARS-CoV-2 vaccination.
Main study parameters/endpoints:
The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as:
- the incidence of COVID-19 after vaccination.
Secondary endpoints are
- mortality
- adverse events of specific interest according to (inter)national authorities in collaboration with LAREB
- presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation
- acute rejection and graft failure in patients after kidney transplantation In a subset of patients additional secondary endpoints will be assessed
- the antibody based immune response at 28 days after completion of SARS-CoV-2 vaccination.
- the durability of antibody based immune response at 6 months compared to at 28 days after having received two subsequent SARS-CoV-2 vaccinations, in patients that have not received a 3rd SARS-CoV-2 vaccine.
- the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination.
The incidence of these endpoints will be compared, if applicable, to those:
- in the general population who are vaccinated
- in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.
详细描述
- OBJECTIVES
Primary objective:
To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination
Secondary Objectives:
- To assess the safety of 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
- 否
入选标准
- •Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- •Age of 18 years or older
- •Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- •eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
- •Hemodialysis, or peritoneal dialysis
- •Kidney Transplant recipient at least 6 weeks after transplantation
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- •Patients who opted out for research in the Santeon, RENINE and NOTR registries.
- •Patients who participate in the RECOVAC-IR study.
- •Of note, patients will be eligible whether or not they have a history of COVID-
- •Analyses will be performed in the overall population, but also shown separately for those without and with a history of COVID-19.
结局指标
主要结局
The incidence of COVID-19
时间窗: two years after SARS-CoV-2 vaccination
After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
次要结局
- Incidence of mortality(two years after SARS-CoV-2 vaccination)
- The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood(28 days after second SARS-CoV-2 vaccination.)
- Incidence of adverse events(two years after SARS-CoV-2 vaccination)
- Incidence of acute rejection or graft failure in kidney transplant recipients(two years after SARS-CoV-2 vaccination)
- Incidence of HLA antibodies measured in blood(two years after SARS-CoV-2 vaccination)
- The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood(28 days after third SARS-CoV-2 vaccination)
研究者
J.S.F. Sanders
Study coordinator
University Medical Center Groningen