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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:
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
The incidence of these endpoints will be compared, if applicable, to those:
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:
Exploratory Objectives:
In a subgroup of participants:
To assess the level of antibody response after vaccination between patients with COVID-19 and without COVID-19 at:
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:
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.
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:
Efficacy in a subgroup of patients:
Exploratory study parameters:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD4/5 | Patients with chronic kidney disease stage G4-G5 without dialysis or with a kidney transplant |
| |
| Dialysis | Patients on hemodialysis and peritoneal dialysis |
| |
| Kidney transplant | Patients with a kidney transplant at least 6 weeks after transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Stephan F Sanders, MD PhD | University Medical Center Groningen | Study Director |
| Marc H Hemmelder, MD PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32243281 | Result | 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. | |
| 33326716 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Blood (in total maximum 1 mL) with a mailer-based finger-prick will be drawn
|
|
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 |
| 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 |
| Result |
| 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. |
| 6595298 | Result | Robison SF, Mayhew RB, Cowan RD, Hawley RJ. Comparative study of deflection characteristics and fragility of 25-, 27-, and 30-gauge short dental needles. J Am Dent Assoc. 1984 Dec;109(6):920-4. doi: 10.14219/jada.archive.1984.0246. No abstract available. |
| 31464823 | Result | 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. |
| 32868447 | Result | 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. |
| 33340043 | Result | 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. |
| 32848205 | Result | 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. |
| Result | Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23 |
| 33151337 | Result | 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. |
| 33125914 | Result | Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27. |
| 21672157 | Result | Katerinis I, Hadaya K, Duquesnoy R, Ferrari-Lacraz S, Meier S, van Delden C, Martin PY, Siegrist CA, Villard J. De novo anti-HLA antibody after pandemic H1N1 and seasonal influenza immunization in kidney transplant recipients. Am J Transplant. 2011 Aug;11(8):1727-33. doi: 10.1111/j.1600-6143.2011.03604.x. Epub 2011 Jun 14. |
| 25072119 | Result | Kotton CN. Immunization after kidney transplantation-what is necessary and what is safe? Nat Rev Nephrol. 2014 Oct;10(10):555-62. doi: 10.1038/nrneph.2014.122. Epub 2014 Jul 29. |
| 33168562 | Result | Mahase E. Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate. BMJ. 2020 Nov 9;371:m4347. doi: 10.1136/bmj.m4347. No abstract available. |
| 32785669 | Result | Noordzij M, Duivenvoorden R, Pena MJ, de Vries H, Kieneker LM; collaborative ERACODA authors. ERACODA: the European database collecting clinical information of patients on kidney replacement therapy with COVID-19. Nephrol Dial Transplant. 2020 Dec 4;35(12):2023-2025. doi: 10.1093/ndt/gfaa179. No abstract available. |
| 33301246 | Result | Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. |
| 30876620 | Result | Reddy S, Chitturi C, Yee J. Vaccination in Chronic Kidney Disease. Adv Chronic Kidney Dis. 2019 Jan;26(1):72-78. doi: 10.1053/j.ackd.2018.10.002. |
| 31477039 | Result | van der Willik EM, Meuleman Y, Prantl K, van Rijn G, Bos WJW, van Ittersum FJ, Bart HAJ, Hemmelder MH, Dekker FW. Patient-reported outcome measures: selection of a valid questionnaire for routine symptom assessment in patients with advanced chronic kidney disease - a four-phase mixed methods study. BMC Nephrol. 2019 Sep 2;20(1):344. doi: 10.1186/s12882-019-1521-9. |
| 31024571 | Result | van Besouw NM, Yan L, de Kuiper R, Klepper M, Reijerkerk D, Dieterich M, Roelen DL, Claas FHJ, Clahsen-van Groningen MC, Hesselink DA, Baan CC. The Number of Donor-Specific IL-21 Producing Cells Before and After Transplantation Predicts Kidney Graft Rejection. Front Immunol. 2019 Apr 9;10:748. doi: 10.3389/fimmu.2019.00748. eCollection 2019. |
| 32640463 | Result | 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. |
| 39272117 | Derived | Vervoort JPM, Konijn WS, Jansen DEMC, Boersma C, de Zeeuw J, Ho-Dac-Pannekeet MM, Gansevoort RT, Messchendorp AL, Sanders JSF, de Wildt-Liesveld R. Patient engagement as a collaborative process in a large Dutch COVID-19 vaccination study (RECOVAC) - insight into the contribution of patient engagement and learnings for the future. Res Involv Engagem. 2024 Sep 13;10(1):96. doi: 10.1186/s40900-024-00622-x. |
| 37533418 | Derived | Frolke SC, Bouwmans P, Messchendorp AL, Vervoort JPM, Abrahams AC, de Vries APJ, Nieuwkerk PT, Hemmelder MH, Gansevoort RT, Hilbrands LB, Reinders MEJ, Sanders JF, Bemelman FJ, Geerlings SE; RECOVAC Collaborators. Adherence to preventive measures after SARS-CoV-2 vaccination and after awareness of antibody response in kidney transplant recipients in the Netherlands: a nationwide questionnaire study. EClinicalMedicine. 2023 Jul 20;62:102103. doi: 10.1016/j.eclinm.2023.102103. eCollection 2023 Aug. |
| 35123437 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |