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

The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Chronic Kidney Diseases; SARS-CoV Infection
• Intervention / Treatment: Diagnostic test: mailer-based finger-prick

Detailed Description

1. 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 having received two subsequent SARS-CoV-2 vaccinations, in a subset of 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.

   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 after vaccination between patients with COVID-19 and without COVID-19 at:

     • 28 days after the 2nd SARS-CoV-2 vaccination
     • 28 days after the 3rd SARS-CoV-2 vaccination
     • 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
   • To assess change in behaviour towards measures against COVID-19 before and after vaccination

   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

2. 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 after the 2nd SARS-CoV-2 vaccination, 28 days after the 3rd SARS-CoV-2 vaccination, and 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd 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.
3. 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 antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the 3rd 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 in patients who did not receive a 3rd 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 after vaccination between patients with COVID-19 and without COVID-19 at:

  • 28 days after the 2nd SARS-CoV-2 vaccination
  • 28 days after the 3rd SARS-CoV-2 vaccination
  • 6 months after the 2nd SARS-CoV-2 vaccination in patients who have not received a 3rd vaccine.
• To assess change in behaviour towards measures against COVID-19 before and 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.

• Study Type: Observational
• Enrollment (Actual): 4868

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

1. Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
2. Age of 18 years or older
3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)

4. 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CKD4/5; Patients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant	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.; Other Names: blood withdrawel
Dialysis; Patients on hemodialysis and peritoneal dialysis	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.; Other Names: blood withdrawel
Kidney transplant; Patients with a kidney transplant at least 6 weeks after transplantation	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.; Other Names: blood withdrawel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of mortality	Incidence of mortality in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.	two years after SARS-CoV-2 vaccination
Incidence of adverse events	Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB	two years after SARS-CoV-2 vaccination
Incidence of acute rejection or graft failure in kidney transplant recipients	Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation	two years after SARS-CoV-2 vaccination
Incidence of HLA antibodies measured in blood	Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation	two years after SARS-CoV-2 vaccination
The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood	The antibody response against the SARS-CoV-2 Receptor Binding Domain	28 days after second SARS-CoV-2 vaccination.
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood	The 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 in patients without a third vaccination.	6 months after second SARS-CoV-2 vaccination
The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood	The antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 28 days after a third vaccination	28 days after third SARS-CoV-2 vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination coverage rate	Percentage of patients vaccinated	two years
SARS-CoV-2 genotype	In patients with active COVID-19 infection	two years
Level of SARS-CoV-2 Receptor Binding Domain antibody in patients with and without COVID-19	level of SARS-CoV-2 Receptor Binding Domain antibody response at 28 days and 6 months after the second SARS-CoV-2 vaccination (in patients who did not receive a third vaccination) or 28 days after the third SARS-CoV-2 vaccination between patients who develop COVID-19 and who do not develop COVID-19 after vaccination	two years
Disease severity of COVID-19 in case of infection assessed by ICU admission	Number of ICU admissions with COVID-19 after vaccination	two years
Disease severity of COVID-19 in case of infection assessed by mechanical ventilation	Number of cases with mechanical ventilation because of COVID-19 after vaccination	two years
Disease severity of COVID-19 in case of infection assessed by mortality	Number of deaths due to COVID-19 after vaccination	two years
Disease severity of COVID-19 in case of infection assessed by hospitalization	Number of hospital admissions with COVID-19 infection after vaccination	two years
Influence of vaccination on health related quality of life - SF-12	Measured by Patient Reported Outcome Measures (PROMs). This is a questionnaire consisting of two parts. The first part includes the 12 items Short Form (SF-12) health survey to monitor physical and mental quality of life (with a score on 8 categories ranging from 0-100; with a higher score defined as a higher quality of life). Scores before and after vaccination will be compared.	two years
Influence of vaccination on health related quality of life - DSI	Measured by Patient Reported Outcome Measures (PROMs). This is a questionnaire consisting of two parts. The second part includes the Dialysis Symptom Index (DSI) questionnaire to monitor disease specific burden from the perspective of patients (with a score ranging from 0-30, with a higher score defined as a higher disease burden). Scores before and after vaccination will be compared.	two years
Change in behaviour towards measures against COVID-19	Estimated by questionnaires, created by the studyteam in collaboration with the Dutch patient association. This questionnaire is focused on mental aspect of COVID-19 measures and whether certain measures, results or extra vaccinations influence behaviour of patients	two years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Study Director: Jan-Stephan F Sanders, MD PhD, University Medical Center Groningen; Principal Investigator: Marc H Hemmelder, MD PhD, Maastricht University Medical Center

Publications and helpful links

General Publications

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• Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258. No abstract available.
• Baric RS. Emergence of a Highly Fit SARS-CoV-2 Variant. N Engl J Med. 2020 Dec 31;383(27):2684-2686. doi: 10.1056/NEJMcibr2032888. Epub 2020 Dec 16. No abstract available.
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• Berends SE, Bloem K, de Vries A, Schaap T, Rispens T, Strik AS, Talwar R, Lowenberg M, D'Haens GR, Mathot RA. Monitoring of Adalimumab Concentrations at Home in Patients with Inflammatory Bowel Disease Using Dried Blood Samples. Ther Drug Monit. 2020 Apr;42(2):289-294. doi: 10.1097/FTD.0000000000000686.
• Dearlove B, Lewitus E, Bai H, Li Y, Reeves DB, Joyce MG, Scott PT, Amare MF, Vasan S, Michael NL, Modjarrad K, Rolland M. A SARS-CoV-2 vaccine candidate would likely match all currently circulating variants. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23652-23662. doi: 10.1073/pnas.2008281117. Epub 2020 Aug 31.
• ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.
• Gansevoort RT, Hilbrands LB. CKD is a key risk factor for COVID-19 mortality. Nat Rev Nephrol. 2020 Dec;16(12):705-706. doi: 10.1038/s41581-020-00349-4.
• Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23
• Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261. Erratum In: Nephrol Dial Transplant. 2021 Feb 24;:
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• Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, Mehrkar A, Evans D, Inglesby P, Cockburn J, McDonald HI, MacKenna B, Tomlinson L, Douglas IJ, Rentsch CT, Mathur R, Wong AYS, Grieve R, Harrison D, Forbes H, Schultze A, Croker R, Parry J, Hester F, Harper S, Perera R, Evans SJW, Smeeth L, Goldacre B. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020 Aug;584(7821):430-436. doi: 10.1038/s41586-020-2521-4. Epub 2020 Jul 8.
• Bouwmans P, Messchendorp AL, Sanders JS, Hilbrands L, Reinders MEJ, Vart P, Bemelman FJ, Abrahams AC, van den Dorpel MA, Ten Dam MA, de Vries APJ, Rispens T, Steenhuis M, Gansevoort RT, Hemmelder MH; RECOVAC Collaborators. Long-term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease, on dialysis or after kidney transplantation: a national prospective observational cohort study. BMC Nephrol. 2022 Feb 5;23(1):55. doi: 10.1186/s12882-022-02680-3.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dialysis; COVID-19 vaccination; SARS-CoV-2 vaccination; Antibody based immune response; Kidney transplant recipients; Chronic kidney disease stage 4-5
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Severe Acute Respiratory Syndrome; COVID-19; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NL76839.042.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No