Covid19RECOVAC-IRNCT04741386
The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study
An observational study of Covid19 and Chronic Kidney Diseases, run by University Medical Center Groningen at 4 sites in Netherlands.
Trial summary
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Chronic Kidney Diseases
- What is being tested?
- SARS-CoV-2 vaccination
- Type of treatment
- Vaccines
- How many people
- 854 participants
- Where
- 4 sitesNetherlands
- Study dates
- 17 Feb 2021to 25 Feb 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * At all four participating centers (UMCG, ErasmusMC, Radboudumc and Amsterdam UMC) out-patient clinics with at least 100 patients with CKD4/5 are available for recruitment in this study. * At all three participating centers approximately 50-100 hemodialysis and peritoneal dialysis patients are being treated, from this population eligible patients will be included. * Kidney transplant recipients at UMCG, Erasmus MC, Radboudumc and Amsterdam UMC will be eligible. In each participating center 130 to 200 patients receive a kidney transplant yearly, and per center 1000-2000 kidney transplant recipients are under regular outpatient follow-up. * Partners, siblings or family members of participating patients will be asked as controls.
Who may be able to join
- All patients should be 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
- Either
- CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
- Hemodialysis, or peritoneal dialysis
- KT recipient at least 6 weeks after transplantation
- Partner, sibling or family member of participating patient
Who cannot join
- 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)
- Multi-organ transplant recipients
- Previous or active COVID-19 disease
- Pregnancy or breastfeeding
- Active (haematological) malignancy
- Inherited immune deficiency
Show all 12Show fewer
- Infection with Human Immunodeficiency Virus (HIV)
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Additional exclusion criterion for patients with CKD stages 4/5, on dialysis and controls:
- Individuals who receive maintenance treatment with immunosuppressive therapy in the 6 months before inclusion, including cytotoxic agents or systemic corticosteroids.
- Additional exclusion criterion for controls:
- severely impaired kidney function, with an eGFR < 45 ml/min*1.73m2 by CKD-EPI
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amsterdam University Medical Center
Amsterdam, North Holland, 1105 AZ
University Medical Center Groningen
Groningen, 9713 GZ
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: The Immune-response and Safety of COVID-19 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant - A Prospective, Controlled, Multicenter Cohort Study by the RECOVAC Consortium
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Read more
Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination).
Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders based on a spike (S)1 specific antibody levels of >=10 or <10 BAU/mL. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs)graded according to severity. Other secondary endpoints include longevity of the immune response at 6 months, antibody respons 28 days after a third vaccination and levels of SARS-CoV-2 specific T and B cell responses.
Read the detailed description
OBJECTIVES
Primary objective:
To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Secondary Objectives:
To assess in these groups of subjects after SARS-CoV 2 vaccination:
- durability of the antibody response
- the SARS-CoV-2-specific T and B cell response
- adverse events
- antibody response after third vaccination in patients on dialysis and kidney transplant recipients
Exploratory Objectives:
To assess in these groups of subjects after SARS-CoV 2 vaccination:
- the association between baseline (immune) parameters and the immune response to SARS-CoV-2 vaccination
- the neutralizing capacity of anti-COVID-19 antibodies
- the incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 6 months after SARS-CoV-2 vaccination and in a subset 28 days after third vaccination
STUDY DESIGN
This is a prospective, controlled multicenter cohort study to evaluate the efficacy and safety after SARS-CoV-2 vaccination in patients with CKD4/5, dialysis patients and kidney transplant recipients as compared to controls. Therefore, 4 cohorts will be included in this study.
- Cohort A: Patients with CKD stages 4 and 5 (eGFR <30 ml/min*1.73m2) (n = 175)
- Cohort B: Patients on hemodialysis and peritoneal dialysis (n = 175)
- Cohort C: Kidney Transplant Recipients (n= 300)
- Cohort D: Controls (n = 200)
Assessment of immune response:
Blood samples will be collected at baseline (i.e. prior to first vaccination) and 28 days, and 6 months after the second vaccination and in a subset 28 days after the third vaccination.
Evaluation other parameters:
To evaluate hematology parameters, liver and kidney function, additional blood samples will be collected at baseline, and 28 days and 6 months after the second vaccination.
Information on clinical course, incidence of SARS-CoV-2 infection, outcome of COVID-19 will be collected up to 6 months after second and in a subset 28 days after third vaccination for descriptive purposes.
METHODS
Main study parameter/endpoint:
The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination as compared to controls.
Secondary study parameters/endpoints:
- Duration and in-depth assessment of immune response through:
- Measurement of SARS-CoV2 specific antibodies at 6 months after vaccination to test the durability of response
- Assessment of SARS-CoV2 specific T and B cell response, 28 days, and 6 months after the second vaccination using a high throughput Interferon ɣ, IL-21 SARSCoV-2 specific T cell ELISPOT and SARS-CoV2 specific B cell memory ELISPOT.
- Safety assessment through:
- Incidence and severity of solicited AEs during 7 days after each vaccination
- Antibody based immune response after third vaccination:
- Measurement of SARS-CoV-2 specific antibodies at 28 days after third vaccination in patients on dialysis and kidney transplantation recipients.
Exploratory study parameters:
- Baseline (immune) parameters associated with vaccination response
- Neutralizing capacity of antibodies to test functionality
- In-depth flow-cytometric analyses for functional and phenotypical characterization of SARS-CoV-2 specific T cell responses will be performed followed by assessment of proliferative capacity, cytokine production and phenotypical markers in a subset of patients.
- Information on incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 6 months after second vaccination and in a subset 28 days after third vaccination will be collected.
- In a substudy in Radboudumc nasal strips will be collected and mucosal antibody response to COVID-19 analysed
- Conditions
- Covid19, Chronic Kidney Diseases
- Being tested
- SARS-CoV-2 vaccination
- Keywords
- SARS-CoV-2 vaccination, Antibody based immune response, SARS-CoV-2 specific T and B cell response
- Medical subject headings
- COVID-19, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccinationBiological
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients with CKD stages 4 and 5 Receives: Biological: SARS-CoV-2 vaccination | |
| Cohort B | Patients on hemodialysis and peritoneal dialysis Receives: Biological: SARS-CoV-2 vaccination | |
| Cohort C | Kidney Transplant Recipients Receives: Biological: SARS-CoV-2 vaccination | |
| Cohort D | Controls Receives: Biological: SARS-CoV-2 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The antibody based immune response to vaccination against COVID-19 as compared to controls
Participants will be classified as responders or non-responders based on seroconversion with a threshold for seropositivity based on Receiver Operator Curve (ROC) analysis and set at 10 BAU/mL in individuals without measurable anti-S antibodies at baseline.
Measured: 28 days after the second vaccination
Secondary outcomes (4)
Longevity of the antibody based immune response
Decline in antibodies and change in antibody response (defined as an antibody concentration above or below 10 BAU/mL)
Measured: 6 months after the second vaccination
SARS-CoV2 specific T and B cell response
using a high throughput Interferon ɣ, IL-21 SARSCoV-2 specific T cell ELISPOT and SARS-CoV2 specific B cell memory ELISPOT
Measured: 28 days and 6 months after the second vaccination
Incidence and severity of solicited adverse events
Using questionaires
Measured: during 7 days after each vaccination
SARS CoV-2 spike-1 specific IgG antibody response after third COVID-19 vaccination
5 drops of blood will be drawn by home finger-prick blood test in a subset of patients
Measured: 28 days after the third vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start17 Feb 2021
- Primary completion4 Jun 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 854 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Radboud University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, J.S.F. Sanders, University Medical Center Groningen
- Investigators
- Jan-Stephan F Sanders, MD PhD, Study director, University Medical Center GroningenRon T Gansevoort, MD PhD, Principal investigator, University Medical Center GroningenLuuk B Hilbrands, MD PhD, Principal investigator, Radboud University Medical CenterMarlies EJ Reinders, MD PhD, Principal investigator, Erasmus Medical CenterFrederike J Bemelman, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741386
- Sponsor's protocol ID
- NL76215.042.20
- Acronym
- RECOVAC-IR
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32243281Gansevoort 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.
PubMed 32848205Gezondheidsraad. 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.
PubMed 33151337Hodgson 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.
PubMed 33125914Katerinis 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.
PubMed 21672157Kotton 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.
PubMed 25072119Mahase 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.
PubMed 33168562Reddy 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.
PubMed 30876620van 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.
PubMed 31024571Williamson 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.
PubMed 32640463Frolke SC, Amirkhan KG, van der Bom-Baylon N, van Gils M, Claireaux M, Geerlings SE, de Vries RD, Sanders JF, Hilbrands LB, Diavatopoulos DA, Messchendorp AL, van Aalderen MC, Remmerswaal EBM, Bemelman FJ. Class switching toward IgG4 six months after primary mRNA-based COVID-19 vaccination in kidney patients. PLoS One. 2026 Mar 3;21(3):e0336320. doi: 10.1371/journal.pone.0336320. eCollection 2026.
PubMed 41774724Vervoort 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.
PubMed 39272117van Eijk LE, Bourgonje AR, Messchendorp AL, Bulthuis MLC, Reinders-Luinge M, Doornbos-van der Meer B, Westra J, den Dunnen WFA, Hillebrands JL, Sanders JF, van Goor H; RECOVAC Collaborators. Systemic oxidative stress may be associated with reduced IgG antibody titers against SARS-CoV-2 in vaccinated kidney transplant recipients: A post-hoc analysis of the RECOVAC-IR observational study. Free Radic Biol Med. 2024 Mar;215:14-24. doi: 10.1016/j.freeradbiomed.2024.02.018. Epub 2024 Feb 22.
PubMed 38395091Sanders JF, Messchendorp AL, de Vries RD, Baan CC, van Baarle D, van Binnendijk R, Diavatopoulos DA, Geers D, Schmitz KS, GeurtsvanKessel CH, den Hartog G, Kho MML, Koopmans MPG, van der Molen RG, Remmerswaal EBM, Rots N, Gansevoort RT, Bemelman FJ, Hilbrands LB, Reinders MEJ; VACcination Immune Response Study (RECOVAC) Collaborators. Antibody and T-Cell Responses 6 Months After Coronavirus Disease 2019 Messenger RNA-1273 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant. Clin Infect Dis. 2023 Feb 8;76(3):e188-e199. doi: 10.1093/cid/ciac557.
PubMed 35796536
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune-response and Safety of COVID-19 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant - A Prospective, Controlled, Multicenter Cohort Study by the RECOVAC Consortium
- ClinicalTrials.gov ID
- NCT04741386
- Acronym / sponsor ID
- RECOVAC-IR / NL76215.042.20
- Conditions
- Covid19, Chronic Kidney Diseases
- Keywords
- SARS-CoV-2 vaccination, Antibody based immune response, SARS-CoV-2 specific T and B cell response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Radboud University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far.
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination).
Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders based on a spike (S)1 specific antibody levels of >=10 or <10 BAU/mL. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs)graded according to severity. Other secondary endpoints include longevity of the immune response at 6 months, antibody respons 28 days after a third vaccination and levels of SARS-CoV-2 specific T and B cell responses.
Detailed description
OBJECTIVES
Primary objective:
To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
Secondary Objectives:
To assess in these groups of subjects after SARS-CoV 2 vaccination:
- durability of the antibody response
- the SARS-CoV-2-specific T and B cell response
- adverse events
- antibody response after third vaccination in patients on dialysis and kidney transplant recipients
Exploratory Objectives:
To assess in these groups of subjects after SARS-CoV 2 vaccination:
- the association between baseline (immune) parameters and the immune response to SARS-CoV-2 vaccination
- the neutralizing capacity of anti-COVID-19 antibodies
- the incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 6 months after SARS-CoV-2 vaccination and in a subset 28 days after third vaccination
STUDY DESIGN
This is a prospective, controlled multicenter cohort study to evaluate the efficacy and safety after SARS-CoV-2 vaccination in patients with CKD4/5, dialysis patients and kidney transplant recipients as compared to controls. Therefore, 4 cohorts will be included in this study.
- Cohort A: Patients with CKD stages 4 and 5 (eGFR <30 ml/min*1.73m2) (n = 175)
- Cohort B: Patients on hemodialysis and peritoneal dialysis (n = 175)
- Cohort C: Kidney Transplant Recipients (n= 300)
- Cohort D: Controls (n = 200)
Assessment of immune response:
Blood samples will be collected at baseline (i.e. prior to first vaccination) and 28 days, and 6 months after the second vaccination and in a subset 28 days after the third vaccination.
Evaluation other parameters:
To evaluate hematology parameters, liver and kidney function, additional blood samples will be collected at baseline, and 28 days and 6 months after the second vaccination.
Information on clinical course, incidence of SARS-CoV-2 infection, outcome of COVID-19 will be collected up to 6 months after second and in a subset 28 days after third vaccination for descriptive purposes.
METHODS
Main study parameter/endpoint:
The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination as compared to controls.
Secondary study parameters/endpoints:
- Duration and in-depth assessment of immune response through:
- Measurement of SARS-CoV2 specific antibodies at 6 months after vaccination to test the durability of response
- Assessment of SARS-CoV2 specific T and B cell response, 28 days, and 6 months after the second vaccination using a high throughput Interferon ɣ, IL-21 SARSCoV-2 specific T cell ELISPOT and SARS-CoV2 specific B cell memory ELISPOT.
- Safety assessment through:
- Incidence and severity of solicited AEs during 7 days after each vaccination
- Antibody based immune response after third vaccination:
- Measurement of SARS-CoV-2 specific antibodies at 28 days after third vaccination in patients on dialysis and kidney transplantation recipients.
Exploratory study parameters:
- Baseline (immune) parameters associated with vaccination response
- Neutralizing capacity of antibodies to test functionality
- In-depth flow-cytometric analyses for functional and phenotypical characterization of SARS-CoV-2 specific T cell responses will be performed followed by assessment of proliferative capacity, cytokine production and phenotypical markers in a subset of patients.
- Information on incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 6 months after second vaccination and in a subset 28 days after third vaccination will be collected.
- In a substudy in Radboudumc nasal strips will be collected and mucosal antibody response to COVID-19 analysed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Biological: SARS-CoV-2 vaccinationPatients with CKD stages 4 and 5 |
| Cohort B | – | Biological: SARS-CoV-2 vaccinationPatients on hemodialysis and peritoneal dialysis |
| Cohort C | – | Biological: SARS-CoV-2 vaccinationKidney Transplant Recipients |
| Cohort D | – | Biological: SARS-CoV-2 vaccinationControls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * At all four participating centers (UMCG, ErasmusMC, Radboudumc and Amsterdam UMC) out-patient clinics with at least 100 patients with CKD4/5 are available for recruitment in this study. * At all three participating centers approximately 50-100 hemodialysis and peritoneal dialysis patients are being treated, from this population eligible patients will be included. * Kidney transplant recipients at UMCG, Erasmus MC, Radboudumc and Amsterdam UMC will be eligible. In each participating center 130 to 200 patients receive a kidney transplant yearly, and per center 1000-2000 kidney transplant recipients are under regular outpatient follow-up. * Partners, siblings or family members of participating patients will be asked as controls.
Key inclusion criteria (8 listed)
- All patients should be 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
- Either
Key exclusion criteria (12 listed)
- 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)
- Multi-organ transplant recipients
- Previous or active COVID-19 disease
- Pregnancy or breastfeeding
- Active (haematological) malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 vaccinationAll participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions. | Biological | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
The antibody based immune response to vaccination against COVID-19 as compared to controls
Time frame: 28 days after the second vaccination
Participants will be classified as responders or non-responders based on seroconversion with a threshold for seropositivity based on Receiver Operator Curve (ROC) analysis and set at 10 BAU/mL in individuals without measurable anti-S antibodies at baseline.
4 secondary outcomes
Longevity of the antibody based immune response
Time frame: 6 months after the second vaccination
SARS-CoV2 specific T and B cell response
Time frame: 28 days and 6 months after the second vaccination
Incidence and severity of solicited adverse events
Time frame: during 7 days after each vaccination
SARS CoV-2 spike-1 specific IgG antibody response after third COVID-19 vaccination
Time frame: 28 days after the third vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 32243281Ahn 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.
- Background: PubMed 32848205Gansevoort 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.
- BackgroundGezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23
- Background: PubMed 33151337Hilbrands 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.
- Background: PubMed 33125914Hodgson 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.
- Background: PubMed 21672157Katerinis 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.
- Background: PubMed 25072119Kotton 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.
- Background: PubMed 33168562Mahase 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.
- Background: PubMed 30876620Reddy 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.
- Background: PubMed 31024571van 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.
- Background: PubMed 32640463Williamson 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.
- Derived from this study: PubMed 41774724Frolke SC, Amirkhan KG, van der Bom-Baylon N, van Gils M, Claireaux M, Geerlings SE, de Vries RD, Sanders JF, Hilbrands LB, Diavatopoulos DA, Messchendorp AL, van Aalderen MC, Remmerswaal EBM, Bemelman FJ. Class switching toward IgG4 six months after primary mRNA-based COVID-19 vaccination in kidney patients. PLoS One. 2026 Mar 3;21(3):e0336320. doi: 10.1371/journal.pone.0336320. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Stephan F Sanders, MD PhD study director
University Medical Center Groningen
Ron T Gansevoort, MD PhD principal investigator
University Medical Center Groningen
Luuk B Hilbrands, MD PhD principal investigator
Radboud University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Chronic Kidney Diseases, run by University Medical Center Groningen at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The antibody based immune response to vaccination against COVID-19 as compared to controls (time frame: 28 days after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741386, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.