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出境医 / 临床实验 / The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19

The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19

Study Description
Brief Summary:
Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.

Condition or disease Intervention/treatment
End Stage Kidney Disease Kidney Transplantion Covid19 Vaccination Biological: SARS - COV 2 VACCINE

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of the Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Actual Study Start Date : April 24, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2023
Arms and Interventions
Group/Cohort Intervention/treatment
ESKD - HD
End Stage Kidney Disease on Long Term Dialysis
 Biological: SARS - COV 2 VACCINE
Vaccination for SARS - COV 2
KTR
Kidney Transplant Recipient
 Biological: SARS - COV 2 VACCINE
Vaccination for SARS - COV 2
Outcome Measures
Primary Outcome Measures :
  1. Efficacy of the vaccine [ Time Frame: 24 months ]
    Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (Naive and memeory T cells - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT cells) at the two respective time points so as to assess alterations induced by vaccination. Serologic response will be estimated by measurement of anti SARS-CoV-2-spike IgGII titer (AU/ml) in the serum (using the ARCHITECT IgG II Quant test (Abbott); titers >50 arbitrary units (AU)/ml are considered positive (detection range, 6.8-80,000 AU/ml); positive agreement, 99.4%; negative agreement, 99.6%).


Secondary Outcome Measures :
  1. Complications caused by the vaccine [ Time Frame: 24 months ]
    Potential side effects associated with the vaccine shall be recorded. Percentages of lymphocytes subsets (as depicted before) in peripheral blood will be measured by flow cytometry. We will compare changes from baseline in the percentages of the lymphocytes subsets following the first and second dose of vaccination between the hemodialysis and kidney transplant recipeints group. In addition we will search for associations between percentages of lymphocytes subsets at diggerent measurement time points and antibody reponse.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
End Stage Kidney Disease and Kidney Transplant Recipients
Criteria

Inclusion Criteria:

  • Age >18 years
  • Covid 19 vaccination

Exclusion Criteria:

  • previous covid infection
  • recent infection
  • chronic infection
  • HBV, HCV, HIV
  • Active malignancy
Contacts and Locations

Contacts
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Contact: Evangelia Ntounousi, PHD +302651007429 edounous@uoi.gr

Locations
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Greece
Evangelia Ntounousi Recruiting
Ioannina, Epirus, Greece, 45110
Contact: Evangelia Ntounousi, PHD       edounous@uoi.gr   
Sponsors and Collaborators
University of Ioannina
Tracking Information
First Submitted Date May 19, 2021
First Posted Date June 21, 2021
Last Update Posted Date September 29, 2021
Actual Study Start Date April 24, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2021) 		Efficacy of the vaccine [ Time Frame: 24 months ]
Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (Naive and memeory T cells - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT cells) at the two respective time points so as to assess alterations induced by vaccination. Serologic response will be estimated by measurement of anti SARS-CoV-2-spike IgGII titer (AU/ml) in the serum (using the ARCHITECT IgG II Quant test (Abbott); titers >50 arbitrary units (AU)/ml are considered positive (detection range, 6.8-80,000 AU/ml); positive agreement, 99.4%; negative agreement, 99.6%).
Original Primary Outcome Measures
 (submitted: June 18, 2021) 		Efficacy of the vaccine [ Time Frame: 24 months ]
Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (NAIVE AND MEMORY T CELLS - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT CELLS) AT THE TWO RESPECTIVE TIME POINTS SO AS TO ASSESS ALTERATIONS INDUCED BY VACCINNATION.
Change History
Current Secondary Outcome Measures
 (submitted: June 22, 2021) 		Complications caused by the vaccine [ Time Frame: 24 months ]
Potential side effects associated with the vaccine shall be recorded. Percentages of lymphocytes subsets (as depicted before) in peripheral blood will be measured by flow cytometry. We will compare changes from baseline in the percentages of the lymphocytes subsets following the first and second dose of vaccination between the hemodialysis and kidney transplant recipeints group. In addition we will search for associations between percentages of lymphocytes subsets at diggerent measurement time points and antibody reponse.
Original Secondary Outcome Measures
 (submitted: June 18, 2021) 		Complications caused by the vaccine [ Time Frame: 24 MONTHS ]
POTENTIAL SIDE EFEFCTS ASSOCIATED WITH THE VACCINE SHALL BE RECORDED.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Official Title Assessment of the Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19
Brief Summary Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population End Stage Kidney Disease and Kidney Transplant Recipients
Condition
  • End Stage Kidney Disease
  • Kidney Transplantion
  • Covid19
  • Vaccination
Intervention Biological: SARS - COV 2 VACCINE
Vaccination for SARS - COV 2
Study Groups/Cohorts
  • ESKD - HD
    End Stage Kidney Disease on Long Term Dialysis
    Intervention: Biological: SARS - COV 2 VACCINE
  • KTR
    Kidney Transplant Recipient
    Intervention: Biological: SARS - COV 2 VACCINE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2021) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age >18 years
  • Covid 19 vaccination

Exclusion Criteria:

  • previous covid infection
  • recent infection
  • chronic infection
  • HBV, HCV, HIV
  • Active malignancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Evangelia Ntounousi, PHD +302651007429 edounous@uoi.gr
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT04932876
Other Study ID Numbers RESCOMUOI82152
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Evangelia Ntounousi, University of Ioannina
Study Sponsor University of Ioannina
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Ioannina
Verification Date September 2021