The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study

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Description

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: durability of t...

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: durability of the antibody response the SARS-CoV-2-specific T and B cell response adverse events Exploratory Objectives: To assess in these groups of subjects after SARS-CoV 2 vaccination: the association between baseline (immune) parameters and the immune response to SARS-CoV-2 vaccination the neutralizing capacity of anti-COVID-19 antibodies the incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 12 months after SARS-CoV-2 vaccination STUDY DESIGN This is a prospective, controlled multicenter cohort study to evaluate the efficacy and safety after SARS-CoV-2 vaccination in patients with CKD4/5, dialysis patients and kidney transplant recipients as compared to controls. Therefore, 4 cohorts will be included in this study. Cohort A: Patients with CKD stages 4 and 5 (eGFR <30 ml/min*1.73m2) (n = 175) Cohort B: Patients on hemodialysis and peritoneal dialysis (n = 175) Cohort C: Kidney Transplant Recipients (n= 300) Cohort D: Controls (n = 200) Assessment of immune response: Blood samples will be collected at baseline (i.e. prior to first vaccination) and 28 days, and 6 and 12 months after the second vaccination. Evaluation other parameters: To evaluate hematology parameters, liver and kidney function, additional blood samples will be collected at baseline, and 28 days and 6 months after the second vaccination. Information on clinical course, incidence of SARS-CoV-2 infection, outcome of COVID-19 will be collected up to 12 months after vaccination for descriptive purposes. METHODS Main study parameter/endpoint: The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination as compared to controls. Secondary study parameters/endpoints: Duration and in-depth assessment of immune response through: Measurement of SARS-CoV2 specific antibodies at 6 and 12 months after vaccination to test the durability of response Assessment of SARS-CoV2 specific T and B cell response, 28 days, and 6 and 12 months after the second vaccination using a high throughput Interferon ?, IL-21 SARSCoV-2 specific T cell ELISPOT and SARS-CoV2 specific B cell memory ELISPOT. Safety assessment through: Incidence and severity of solicited AEs during 7 days after each vaccination Exploratory study parameters: Baseline (immune) parameters associated with vaccination response Neutralizing capacity of antibodies to test functionality In-depth flow-cytometric analyses for functional and phenotypical characterization of SARS-CoV-2 specific T cell responses will be performed followed by assessment of proliferative capacity, cytokine production and phenotypical markers in a subset of patients. Information on incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 12 months after vaccination will be collected. In a substudy in Radboudumc nasal strips will be collected and mucosal antibody response to COVID-19 analysed

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