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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Completed

CT.gov ID

NCT05465863

Collaborator

Scientific Research Projects Coordination Unit of Istanbul University-Cerrahpasa. (Other)

101

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

16.8

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease 5D Chronic Kidney Disease 5T	Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients	Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) 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
Active Comparator: Healthy controls	Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) 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

Arm

Intervention/Treatment

Active Comparator: Patients

Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)

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

Active Comparator: Healthy controls

Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)

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

Outcome Measures

Primary Outcome Measures

Evaluation of the antibody response following vaccination [one month after the second dose of the vaccine]
Anti-SARS-CoV-2 IgG Quantification and Neutralisation test

Secondary Outcome Measures

Evaluation of the cellular response following vaccination [one month after the second dose of the vaccine]
Interferon Gamma Release Assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Istanbul University-Cerrahpasa	Istanbul	Turkey	34098
2	Istanbul University, Istanbul School of Medicine	Istanbul	Turkey
3	Istinye University, School of Medicine	Istanbul	Turkey
4	Marmara University, School of Medicine	Istanbul	Turkey
5	Medeniyet University, School of Medicine	Istanbul	Turkey
6	Memorial Hospital	Istanbul	Turkey