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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932876
• Other study ID #: RESCOMUOI82152
• Status: Recruiting
• Start date: April 24, 2021
• Est. completion date: March 2023

Study information

• Verified date: September 2021
• Source: University of Ioannina
• Contact: Evangelia Ntounousi, PHD
• Phone: +302651007429
• Email: edounous[@]uoi.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age >18 years

• Covid 19 vaccination

Exclusion Criteria:

• previous covid infection

• recent infection

• chronic infection

• HBV, HCV, HIV

• Active malignancy

Related Conditions & MeSH terms

• COVID-19
• Covid19
• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplantion
• Vaccination

Intervention

Biological:
• SARS - COV 2 VACCINE
Vaccination for SARS - COV 2

Locations

Country	Name	City	State
Greece	Evangelia Ntounousi	Ioannina	Epirus

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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