The Immune-response and Safety of COVID-19 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant - A Prospective, Controlled, Multicenter Cohort Study by the RECOVAC Consortium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 854
- 试验地点
- 4
- 主要终点
- The antibody based immune response to vaccination against COVID-19 as compared to controls
研究概览
简要总结
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination).
Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders based on a spike (S)1 specific antibody levels of >=10 or <10 BAU/mL. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs)graded according to severity. Other secondary endpoints include longevity of the immune response at 6 months, antibody respons 28 days after a third vaccination and levels of SARS-CoV-2 specific T and B cell responses.
详细描述
OBJECTIVES
Primary objective:
To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Secondary Objectives:
To assess in these groups of subjects after SARS-CoV 2 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
- •All patients should be 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
- •CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
- •Hemodialysis, or peritoneal dialysis
- •KT recipient at least 6 weeks after transplantation
- •Partner, sibling or family member of participating patient
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)
- •Multi-organ transplant recipients
- •Previous or active COVID-19 disease
- •Pregnancy or breastfeeding
- •Active (haematological) malignancy
- •Inherited immune deficiency
- •Infection with Human Immunodeficiency Virus (HIV)
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Additional exclusion criterion for patients with CKD stages 4/5, on dialysis and controls:
- •Individuals who receive maintenance treatment with immunosuppressive therapy in the 6 months before inclusion, including cytotoxic agents or systemic corticosteroids.
- •Additional exclusion criterion for controls:
- •severely impaired kidney function, with an eGFR < 45 ml/min*1.73m2 by CKD-EPI
结局指标
主要结局
The antibody based immune response to vaccination against COVID-19 as compared to controls
时间窗: 28 days after the second vaccination
Participants will be classified as responders or non-responders based on seroconversion with a threshold for seropositivity based on Receiver Operator Curve (ROC) analysis and set at 10 BAU/mL in individuals without measurable anti-S antibodies at baseline.
次要结局
- Longevity of the antibody based immune response(6 months after the second vaccination)
- Incidence and severity of solicited adverse events(during 7 days after each vaccination)
- SARS-CoV2 specific T and B cell response(28 days and 6 months after the second vaccination)
- SARS CoV-2 spike-1 specific IgG antibody response after third COVID-19 vaccination(28 days after the third vaccination)
研究者
J.S.F. Sanders
MD PhD
University Medical Center Groningen