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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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End Stage Kidney Disease, Kidney Transplantion, Covid19, Vaccination

Intervention / Treatment
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* Biological: SARS - COV 2 VACCINE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Covid 19 vaccination Exclusion Criteria: previous covid infection recent infection chronic infection HBV, HCV, HIV Active malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESKD - HD<br>End Stage Kidney Disease on Long Term Dialysis | Biological: SARS - COV 2 VACCINE<br>* Vaccination for SARS - COV 2<br>|
| KTR<br>Kidney Transplant Recipient | Biological: SARS - COV 2 VACCINE<br>* Vaccination for SARS - COV 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the vaccine | 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%). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications caused by the vaccine | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End Stage Kidney Disease, Kindey Trasplantation, Immune System, Covid19 Vaccination