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Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases

Primary Purpose

Chronic Kidney Disease 5D, Chronic Kidney Disease 5T

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease 5D focused on measuring children, chronic kidney disease, covid19, vaccination, antibody response

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 12-21 year-old chronic kidney diseases and dialysis patients

Exclusion Criteria:

  • Patients with primary immune deficiencies and not vaccinated with SARS-CoV-2 mRNA BNT162b2 vaccine
  • Patients who did not completed 2 series of SARS-CoV-2 mRNA BNT162b2 vaccine

Sites / Locations

  • Istanbul University-Cerrahpasa
  • Istanbul University, Istanbul School of Medicine
  • Istinye University, School of Medicine
  • Marmara University, School of Medicine
  • Medeniyet University, School of Medicine
  • Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the antibody response following vaccination
Anti-SARS-CoV-2 IgG Quantification and Neutralisation test

Secondary Outcome Measures

Evaluation of the cellular response following vaccination
Interferon Gamma Release Assay

Full Information

First Posted
July 19, 2022
Last Updated
July 19, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05465863
Brief Title
Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases
Official Title
Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Pediatric Kidney Transplant Recipients Compared to Dialysis Patients and Healthy Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant recipients (KTRs). Although children had lower morbidity and mortality, KTRs are more vulnerable than healthy children. It has already known that the general immune responses to vaccines, which are currently in practice (attenuated, conjugated, or recombinant) were lower than healthy controls in children and adolescents on dialysis and with a kidney transplantation. Uremic milieu and immunosuppressive drugs are the factors causing impaired immune response in this group of patients. The new mRNA vaccine technology is used worldwide including children and adolescents during the pandemic. Studies have demonstrated lower immune response to new SARS-CoV-2 mRNA vaccine in adult KTRs. However, there is limited data about vaccine-induced immune response in children and adolescent with renal replacement therapy. The aim of this study was to assess immune response to SARS-CoV-2 mRNA BNT162b2 and its clinical and laboratory correlates in children and adolescent KTRs. Humoral immune response was assessed by anti-SARS-CoV-2 immunoglobulin G (Anti-S IgG) and its clinical correlate neutralizing antibody (nAb). Cellular immune response was assessed with SARS-CoV-2 specific Interferon ɣ release assay (IGRA).
Detailed Description
This is a prospective, multicenter case-control study performed between September 2021 and March 2022 in the Pediatric Nephrology Units of IU- Cerrahpaşa School of Medicine, Memorial Hospital, Marmara University School of Medicine, IU- Istanbul School of Medicine, Medeniyet University School of Medicine, and Istinye University School of Medicine. The control group has consisted of age and gender comparable 19 healthy children without any acute infection or chronic disease, who were admitted to Cerrahpasa School of Medicine, Pediatric out-patient unit for routine control. When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedule an appointment. The SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) administered to all participants by intramuscular route in the deltoid region. At least one month after the second dose of the vaccine, serum samples and whole blood samples were collected from all patients and controls, to analyze the humoral and cellular immune response to the vaccine. All samples were stored at -20 ◦C until testing. SARS-CoV-2 PCR test results were recorded retrospectively to determine natural infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease 5D, Chronic Kidney Disease 5T
Keywords
children, chronic kidney disease, covid19, vaccination, antibody response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Active Comparator
Arm Title
Healthy controls
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
Intervention Description
When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedule an appointment
Primary Outcome Measure Information:
Title
Evaluation of the antibody response following vaccination
Description
Anti-SARS-CoV-2 IgG Quantification and Neutralisation test
Time Frame
one month after the second dose of the vaccine
Secondary Outcome Measure Information:
Title
Evaluation of the cellular response following vaccination
Description
Interferon Gamma Release Assay
Time Frame
one month after the second dose of the vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 12-21 year-old chronic kidney diseases and dialysis patients Exclusion Criteria: Patients with primary immune deficiencies and not vaccinated with SARS-CoV-2 mRNA BNT162b2 vaccine Patients who did not completed 2 series of SARS-CoV-2 mRNA BNT162b2 vaccine
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul University, Istanbul School of Medicine
City
Istanbul
Country
Turkey
Facility Name
Istinye University, School of Medicine
City
Istanbul
Country
Turkey
Facility Name
Marmara University, School of Medicine
City
Istanbul
Country
Turkey
Facility Name
Medeniyet University, School of Medicine
City
Istanbul
Country
Turkey
Facility Name
Memorial Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases

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