Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases
Condition: Chronic Kidney Disease 5D; Chronic Kidney Disease 5T
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

Intervention name(s): SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
Intervention type(s): Biological
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; chronic kidney disease; covid19; vaccination; antibody response