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

Rövid összefoglaló (regiszter, angolul)

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.

Mit vállalsz

• Vizsgálat típusa: Megfigyeléses
• Bevont résztvevők: 4868
• 2021. ápr. 22. és az elsődleges befejezés (2021. nov. 30.) között
• 1 helyszín, 1 országban
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