Covid19, End Stage Kidney Disease, Kidney Transplantion, Vaccination
Conditions
Keywords
End Stage Kidney Disease, Kindey Trasplantation, Immune System, Covid19 Vaccination
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.
Interventions
BIOLOGICALSARS - COV 2 VACCINE
Vaccination for SARS - COV 2
Sponsors
University of Ioannina
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Covid 19 vaccination
Exclusion criteria
* previous covid infection * recent infection * chronic infection * HBV, HCV, HIV * Active malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the vaccine | 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
| Measure | Time frame | Description |
|---|---|---|
| Complications caused by the vaccine | 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. |
Countries
Greece
Contacts
Primary ContactEvangelia Ntounousi, PHD
Outcome results
None listed