Chronic Kidney Disease 5DNCT05465863
Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases
A study testing SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) in people with Chronic Kidney Disease 5D and Chronic Kidney Disease 5T, run by Istanbul University - Cerrahpasa at 6 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease 5D, Chronic Kidney Disease 5T
- What is being tested?
- SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Mar 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-21 year-old chronic kidney diseases and dialysis patients
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Istanbul University-Cerrahpasa
Istanbul, 34098
Istanbul University, Istanbul School of Medicine
Istanbul
Istinye University, School of Medicine
Istanbul
Marmara University, School of Medicine
Istanbul
Medeniyet University, School of Medicine
Istanbul
Memorial Hospital
Istanbul
About this study
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
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).
Read the 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.
- Being tested
- SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
- Keywords
- children, chronic kidney disease, covid19, vaccination, antibody response
- Medical subject headings
- Renal Insufficiency, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Not described Receives: Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) |
| Healthy controls | Active comparator | Not described Receives: Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the antibody response following vaccination
Anti-SARS-CoV-2 IgG Quantification and Neutralisation test
Measured: one month after the second dose of the vaccine
Secondary outcomes (1)
Evaluation of the cellular response following vaccination
Interferon Gamma Release Assay
Measured: one month after the second dose of the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Kiykim, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465863
- Sponsor's protocol ID
- COVIDCKD
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36459243