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Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

NCT05620251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

  • type1diabetes

Interventions

DIAGNOSTIC_TEST

Blood test

Assessment of humoral immune response

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Hamdi C Emeksiz, MD · Istanbul Medeniyet University

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-02-28
Completion
2022-06-12

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620251 on ClinicalTrials.gov