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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841785
Recruitment Status : Active, not recruiting
First Posted : April 12, 2021
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
J.S.F. Sanders, University Medical Center Groningen

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.

Condition or disease Intervention/treatment
Covid19 SARS-CoV Infection Chronic Kidney Diseases Diagnostic Test: mailer-based finger-prick

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Study Type : Observational
Actual Enrollment : 4914 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : December 31, 2023


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 Name: 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 Name: 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 Name: blood withdrawel




Primary Outcome Measures :
  1. The incidence of COVID-19 [ Time Frame: two years after SARS-CoV-2 vaccination ]
    After SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.


Secondary Outcome Measures :
  1. Incidence of mortality [ Time Frame: two years after SARS-CoV-2 vaccination ]
    Incidence of mortality in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.

  2. Incidence of adverse events [ Time Frame: two years after SARS-CoV-2 vaccination ]
    Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB

  3. Incidence of acute rejection or graft failure in kidney transplant recipients [ Time Frame: two years after SARS-CoV-2 vaccination ]
    Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation

  4. Incidence of HLA antibodies measured in blood [ Time Frame: two years after SARS-CoV-2 vaccination ]
    Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation

  5. The antibody level against the SARS-CoV-2 Receptor Binding Domain measured in blood [ Time Frame: 28 days after second SARS-CoV-2 vaccination. ]
    The antibody response against the SARS-CoV-2 Receptor Binding Domain

  6. The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood [ Time Frame: 6 months after second SARS-CoV-2 vaccination ]
    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.

  7. The antibody level against SARS-CoV-2 Receptor Binding Domain measured in blood [ Time Frame: 28 days after third SARS-CoV-2 vaccination ]
    The antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 28 days after a third vaccination


Other Outcome Measures:
  1. Vaccination coverage rate [ Time Frame: two years ]
    Percentage of patients vaccinated

  2. SARS-CoV-2 genotype [ Time Frame: two years ]
    In patients with active COVID-19 infection

  3. Level of SARS-CoV-2 Receptor Binding Domain antibody in patients with and without COVID-19 [ Time Frame: two years ]
    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

  4. Disease severity of COVID-19 in case of infection assessed by ICU admission [ Time Frame: two years ]
    Number of ICU admissions with COVID-19 after vaccination

  5. Disease severity of COVID-19 in case of infection assessed by mechanical ventilation [ Time Frame: two years ]
    Number of cases with mechanical ventilation because of COVID-19 after vaccination

  6. Disease severity of COVID-19 in case of infection assessed by mortality [ Time Frame: two years ]
    Number of deaths due to COVID-19 after vaccination

  7. Disease severity of COVID-19 in case of infection assessed by hospitalization [ Time Frame: two years ]
    Number of hospital admissions with COVID-19 infection after vaccination

  8. Influence of vaccination on health related quality of life - SF-12 [ Time Frame: two years ]
    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.

  9. Influence of vaccination on health related quality of life - DSI [ Time Frame: two years ]
    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.

  10. Change in behaviour towards measures against COVID-19 [ Time Frame: two years ]
    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


Biospecimen Retention:   Samples Without DNA
Blood (in total maximum 1 mL) with a mailer-based finger-prick will be drawn


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841785


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Study Director: Jan-Stephan F Sanders, MD PhD University Medical Center Groningen
Principal Investigator: Marc H Hemmelder, MD PhD Maastricht University Medical Center
Publications of Results:
Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J.S.F. Sanders, Study coordinator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04841785    
Other Study ID Numbers: NL76839.042.21
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J.S.F. Sanders, University Medical Center Groningen:
Kidney transplant recipients
Dialysis
Chronic kidney disease stage 4-5
SARS-CoV-2 vaccination
COVID-19 vaccination
Antibody based immune response
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Kidney Diseases
Renal Insufficiency, Chronic
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency