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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Kidney Disease
- Sponsor
- University of Ioannina
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy of the vaccine
- Last Updated
- 4 years ago
Overview
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.
Investigators
Evangelia Ntounousi
Assistant Professor Of Nephrology
University of Ioannina
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years
- •Covid 19 vaccination
Exclusion Criteria
- •previous covid infection
- •recent infection
- •chronic infection
- •HBV, HCV, HIV
- •Active malignancy
Outcomes
Primary Outcomes
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 Outcomes
- Complications caused by the vaccine(24 months)