Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients

Summary

Participation Requirements

Description

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 v...

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 In a subgroup of participants: To assess the level of antibody response at 28 days and 6 months after SARS-CoV-2 vaccination To assess durability of the antibody response at 6 months after SARS-CoV-2 vaccination Exploratory Objectives: The vaccination coverage rate The severity of COVID-19 in case of infection The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in patients on dialysis. The SARS-CoV-2 genotype in patients with COVID-19 In a subgroup of participants: - To assess the level of antibody response at 28 days and 6 months after SARS-CoV-2 vaccination between patients with COVID-19 and without COVID-19 If data are available and applicable, outcomes in vaccinated patients on dialysis or after kidney transplantation will be compared: with outcomes in the general population with outcomes in patients with severely impaired kidney function (CKD stages G4/5), on dialysis or with a kidney transplant who are not vaccinated. according to the type of vaccination they received STUDY DESIGN This is a prospective observational registry-based cohort study to evaluate the long-term efficacy and safety after SARS-CoV-2 vaccination on clinically important outcomes in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. All participants will receive vaccination against COVID-19 via the national vaccination program and according to the manufacturer's instructions. To assess the immune response after vaccination, blood samples will be collected at 28 days and 6 months after complete vaccination. In total a maximum of 1 ml blood will be drawn. Data of the following cohorts will be analyzed in this study. Patiens with chronic kidney disease stage G4-G5, data to be derived from the Santeon hospitals. Patients on hemodialysis and peritoneal dialysis, data to be derived from the existing national registry RENINE Kidney transplant recipients, data to be derived from the existing national registry NOTR Patients on dialysis or after kidney transplantation with COVID-19 disease, data to be derived from the ERACODA database. METHODS Main study parameter/endpoint: The primary endpoints is the incidence of COVID-19 in a two years period after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. Secondary study parameters/endpoints: Safety in all patients: Incidence of mortality Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation Efficacy in a subgroup of patients: The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the final SARS-CoV-2 vaccination. The durability of antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination. Exploratory study parameters: Vaccination coverage rates Disease severity in patients who develop COVID-19, assessed as Hospitalization ICU admission Mechanical ventilation Mortality The influence of vaccination on health-related quality of life by patient reported outcome measures (PROMs) in dialysis patients SARS-CoV-2 genotype in patients with COVID-19 In a subgroup of participants: - To assess the level of SARS-CoV-2 Receptor Binding Domain antibody response at 28 days and 6 months after SARS-CoV-2 vaccination between patients who develop COVID-19 and who do not develop COVID-19 after vaccination These data collected after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and after a kidney transplantation will (if applicable data are available) be compared: to those obtained in the general population to those obtained in patients with chronic kidney disease stage G4-G5, on dialysis or with a kidney transplant who are not vaccinated according to the type of vaccination received These comparisons will allow us to analyze whether SARS-CoV-2 vaccination offers efficacy to prevent COVID-19 and sufficient safety in patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients when compared to non-vaccinated patients with chronic kidney disease stage G4-G5, dialysis and kidney transplant patients, whether the efficacy is similar as in the general population, and whether there are differences in the risk-benefit ratio between the various vaccines.

Tracking Information