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

• Conditions: Covid19; Vaccination; End Stage Kidney Disease; Kidney Transplantion
• Interventions: Biological: SARS - COV 2 VACCINE

• Registration Number: NCT04932876
• Lead Sponsor: University of Ioannina

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 available

Study Timeline

• Study Start: 2021-04-24
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18 years
• Covid 19 vaccination

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KTR	SARS - COV 2 VACCINE	Kidney Transplant Recipient
ESKD - HD	SARS - COV 2 VACCINE	End Stage Kidney Disease on Long Term Dialysis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Evangelia Ntounousi; 🇬🇷 Ioannina, Epirus, Greece