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

Summary

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.

Conditions

• Covid19
• SARS-CoV Infection
• Chronic Kidney Diseases

Interventions

DIAGNOSTIC_TEST

mailer-based finger-prick

All participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory.

Sponsors & Collaborators

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Jan-Stephan F Sanders, MD PhD · University Medical Center Groningen

• Marc H Hemmelder, MD PhD · Maastricht University Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-22

Primary Completion

2021-11-30

Completion

2023-12-18

Countries

• Netherlands

Study Locations