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

NCT04932876 | Unknown

• 1 other identifier: RESCOMUOI82152
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Kidney Disease; Kidney Transplantion; Covid19; Vaccination

Keywords

End Stage Kidney Disease; Kindey Trasplantation; Immune System; Covid19 Vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications caused by the vaccine

  24 months

Study Arms (2)

ESKD - HD

End Stage Kidney Disease on Long Term Dialysis

Biological: SARS - COV 2 VACCINE

KTR

Kidney Transplant Recipient

Biological: SARS - COV 2 VACCINE

Interventions

SARS - COV 2 VACCINE BIOLOGICAL

Vaccination for SARS - COV 2

ESKD - HD; KTR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End Stage Kidney Disease and Kidney Transplant Recipients

You may qualify if:

• Age \>18 years
• Covid 19 vaccination

You may not qualify if:

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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Evangelia Ntounousi

Ioannina, Epirus, 45110, Greece

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Evangelia Ntounousi, PHD

CONTACT

+302651007429; edounous@uoi.gr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Of Nephrology

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 21, 2021
• Study Start: April 24, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

GR (1)