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

Sponsor

University of Ioannina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04932876

Collaborator

(none)

100

Enrollment

Location

22.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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	Phase
End Stage Kidney Disease Kidney Transplantion Covid19 Vaccination	Biological: SARS - COV 2 VACCINE

Study Design

Study Type:

Observational

Anticipated 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 :

Apr 24, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	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

Arm

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

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Evangelia Ntounousi	Ioannina	Epirus	Greece	45110

Sponsors and Collaborators

University of Ioannina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Evangelia Ntounousi, Assistant Professor Of Nephrology, University of Ioannina

ClinicalTrials.gov Identifier:

NCT04932876

Other Study ID Numbers:

RESCOMUOI82152

First Posted:

Jun 21, 2021

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Evangelia Ntounousi, Assistant Professor Of Nephrology, University of Ioannina

End Stage Kidney Disease

Kindey Trasplantation

Immune System

Covid19 Vaccination

Additional relevant MeSH terms:

COVID-19

Kidney Diseases

Kidney Failure, Chronic

Study Results

No Results Posted as of Sep 29, 2021