Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases
1 other identifier
interventional
101
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedJuly 20, 2022
July 1, 2022
5 months
July 19, 2022
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the antibody response following vaccination
Anti-SARS-CoV-2 IgG Quantification and Neutralisation test
one month after the second dose of the vaccine
Secondary Outcomes (1)
Evaluation of the cellular response following vaccination
one month after the second dose of the vaccine
Study Arms (2)
Patients
ACTIVE COMPARATORHealthy controls
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- year-old chronic kidney diseases and dialysis patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Istanbul University-Cerrahpasa
Istanbul, 34098, Turkey (Türkiye)
Istanbul University, Istanbul School of Medicine
Istanbul, Turkey (Türkiye)
Istinye University, School of Medicine
Istanbul, Turkey (Türkiye)
Marmara University, School of Medicine
Istanbul, Turkey (Türkiye)
Medeniyet University, School of Medicine
Istanbul, Turkey (Türkiye)
Memorial Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
Gulmez R, Ozbey D, Agbas A, Aksu B, Yildiz N, Uckardes D, Saygili S, Yilmaz EK, Yildirim ZY, Tasdemir M, Kiykim A, Cokugras H, Canpolat N, Nayir A, Kocazeybek B, Caliskan S. Humoral and cellular immune response to SARS-CoV-2 mRNA BNT162b2 vaccine in pediatric kidney transplant recipients compared with dialysis patients and healthy children. Pediatr Nephrol. 2023 Jul;38(7):2199-2208. doi: 10.1007/s00467-022-05813-w. Epub 2022 Dec 2.
PMID: 36459243DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 20, 2022
Study Start
September 1, 2021
Primary Completion
February 1, 2022
Study Completion
March 1, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share