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Completed NCT05620251

Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Conditions: type1diabetes

Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: 1
Enrollment: 121
Sponsor: Istanbul Medeniyet University

Location: Turkey

Summary

Adolescents with type 1 diabetes may be at increased risk for severe coronavirus disease-2019 (COVID-19) and are therefore prioritized for access to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. The pivotal trial that assessed the efficacy of the BNT162b2 vaccine among adolescents demonstrated 100% protection against SARS-CoV-2 infection after a two-dose regimen. However, the research did not include adolescents with type 1 diabetes. In this study, the investigators aimed to assess the humoral immune response of infection-naive adolescents with type 1 diabetes following vaccination with the BNT162b2 vaccine in comparison to that of infection-naive healthy controls and the factors associated with that response.

Eligibility Criteria

Inclusion Criteria for adolescents with type 1 diabetes:aged between 12-18 yearshistory of diabeteswillingness to provide informed consentExclusion Criteria for adolescents with type 1 diabetes:age < 12 years and age > 18 yearshistory of chronic diseaseprevious episode of COVID-19respiratory symptoms up to 14 days before the studyhistory of systematic treatment with corticosteroids and/or immunosuppressant medicationsInclusion Criteria for controls:aged between 12-18 yearsgood healthno previous history of diabeteswillingness to provide informed consentExclusion Criteria for controls:age < 12 years and age > 18 yearshistory of chronic diseaseprevious episode of COVID-19respiratory symptoms up to 14 days before the studyhistory of systematic treatment with corticosteroids and/or immunosuppressant medications

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05620251). StuddyBuddy aggregates publicly available trial information.