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The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study (RECOVAC-IR)

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: NCT04741386
Recruitment Status : Active, not recruiting
First Posted : February 5, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborators:
Erasmus Medical Center
Radboud University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 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 year 1 after 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. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. 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 and 12 months and levels of SARS-CoV-2 specific T and B cell responses.


Condition or disease Intervention/treatment
Covid19 Chronic Kidney Diseases Biological: SARS-CoV-2 vaccination

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Study Type : Observational [Patient Registry]
Actual Enrollment : 849 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : February 17, 2021
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort A
Patients with CKD stages 4 and 5
Biological: SARS-CoV-2 vaccination
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.

Cohort B
Patients on hemodialysis and peritoneal dialysis
Biological: SARS-CoV-2 vaccination
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.

Cohort C
Kidney Transplant Recipients
Biological: SARS-CoV-2 vaccination
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.

Cohort D
Controls
Biological: SARS-CoV-2 vaccination
All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.




Primary Outcome Measures :
  1. The antibody based immune response to vaccination against COVID-19 as compared to controls [ Time Frame: 28 days after the second vaccination ]
    The definition of response will be based on the latest available data from the pivotal studies


Secondary Outcome Measures :
  1. Longevity of the antibody based immune response [ Time Frame: 6 and 12 months after the second vaccination ]
    The definition of response will be based on the latest available data from the pivotal studies

  2. SARS-CoV2 specific T and B cell response [ Time Frame: 28 days, 6 and 12 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

  3. Incidence and severity of solicited adverse events [ Time Frame: during 7 days after each vaccination ]
    Using questionaires


Biospecimen Retention:   Samples Without DNA
In total 4x10 ml heparin blood, 15 ml EDTA blood and 10 mL serum 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:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. All patients should be 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
  4. 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

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)
  • Multi-organ transplant recipients
  • Previous or active COVID-19 disease
  • Pregnancy or breastfeeding
  • Active (haematological) malignancy
  • Inherited immune deficiency
  • 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


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): NCT04741386


Locations
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Netherlands
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525 GA
Amsterdam University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Erasmus Medical Center
Radboud University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Director: Jan-Stephan F Sanders, MD PhD University Medical Center Groningen
Principal Investigator: Ron T Gansevoort, MD PhD University Medical Center Groningen
Principal Investigator: Luuk B Hilbrands, MD PhD Radboud University
Principal Investigator: Marlies EJ Reinders, MD PhD Erasmus Medical Center
Principal Investigator: Frederike J Bemelman, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications:
Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020; publicatienr. 2020/23

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Responsible Party: J.S.F. Sanders, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04741386    
Other Study ID Numbers: NL76215.042.20
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
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:
SARS-CoV-2 vaccination
Antibody based immune response
SARS-CoV-2 specific T and B cell response
Additional relevant MeSH terms:
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COVID-19
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs