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

NCT04841785 | Completed DMC

• 1 other identifier: NL76839.042.21
• Study Type: observational
• Target: 4,868
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kidney transplant recipients; Dialysis; Chronic kidney disease stage 4-5; SARS-CoV-2 vaccination; COVID-19 vaccination; Antibody based immune response

Outcome Measures

Primary Outcomes (1)

• The incidence of COVID-19

  After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.

  two years after SARS-CoV-2 vaccination

Secondary Outcomes (7)

• Incidence of mortality

  two years after SARS-CoV-2 vaccination

• Incidence of adverse events

  two years after SARS-CoV-2 vaccination

• Incidence of acute rejection or graft failure in kidney transplant recipients

  two years after SARS-CoV-2 vaccination

• Incidence of HLA antibodies measured in blood

  two years after SARS-CoV-2 vaccination

• The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood

  28 days after second SARS-CoV-2 vaccination.

Other Outcomes (10)

• Vaccination coverage rate

  two years

• SARS-CoV-2 genotype

  two years

• Level of SARS-CoV-2 Receptor Binding Domain antibody in patients with and without COVID-19

  two years

Study Arms (3)

CKD4/5

Patients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant

Diagnostic Test: mailer-based finger-prick

Dialysis

Patients on hemodialysis and peritoneal dialysis

Diagnostic Test: mailer-based finger-prick

Kidney transplant

Patients with a kidney transplant at least 6 weeks after transplantation

Diagnostic Test: mailer-based finger-prick

Interventions

mailer-based finger-prick DIAGNOSTIC_TEST

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.

Also known as: blood withdrawel

CKD4/5; Dialysis; Kidney transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Patients with chronic kidney disease stage G4-G5 from the Santeon registry * Patients on hemodialysis and peritoneal dialysis who gave informed consent for participating in the national registry RENINEKidney transplant recipients who gave informed consent for participating in the national registry NOTR

You may qualify if:

• 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 (signed informed consent form has been obtained)
• Either
• eGFR \< 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
• Hemodialysis, or peritoneal dialysis
• Kidney Transplant recipient at least 6 weeks after transplantation

You may not qualify if:

• 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).
• Patients who opted out for research in the Santeon, RENINE and NOTR registries.
• Patients who participate in the RECOVAC-IR study.
• Of note, patients will be eligible whether or not they have a history of COVID-19. Analyses will be performed in the overall population, but also shown separately for those without and with a history of COVID-19.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (in total maximum 1 mL) with a mailer-based finger-prick will be drawn

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan-Stephan F Sanders, MD PhD

  University Medical Center Groningen

  STUDY DIRECTOR

• Marc H Hemmelder, MD PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 12, 2021
• Study Start: April 22, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 18, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

NL (1)