Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

NCT05620251 | Completed

• 1 other identifier: 2022/0190
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

type 1 diabetes; SARS-CoV-2; immunogenicity; antibody; covid-19; adolescents; vaccine; BNT162b2

Outcome Measures

Primary Outcomes (2)

• humoral immune response after first vaccine dose

  Levels of antibodies detected against SARSCoV2

  28 days after first vaccine dose

• humoral immune response after second vaccine dose

  Levels of antibodies detected against SARSCoV2

  28 days after second vaccine dose

Secondary Outcomes (1)

• Adverse events

  up to 28 days after first vaccine dose and up to 28 days after second vaccine dose

Study Arms (2)

COVID-19 infection-naive adolescents with type 1 diabetes

Diagnostic Test: Blood test

COVID-19 infection-naive healthy controls

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Assessment of humoral immune response

COVID-19 infection-naive adolescents with type 1 diabetes; COVID-19 infection-naive healthy controls

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

SARSCoV2-naive adolescents with type 1 diabetes and SARSCoV2-naive healthy control adolescents who will undergo blood sampling for testing levels of antibodies against SARSCoV2 after SARSCoV2 vaccination will be consecutively included in this prospective study.

You may qualify if:

• aged between 12-18 years
• history of diabetes
• willingness to provide informed consent

You may not qualify if:

• age \< 12 years and age \> 18 years
• history of chronic disease
• previous episode of COVID-19
• respiratory symptoms up to 14 days before the study
• history of systematic treatment with corticosteroids and/or immunosuppressant medications
• aged between 12-18 years
• good health
• no previous history of diabetes
• willingness to provide informed consent
• age \< 12 years and age \> 18 years
• history of chronic disease
• previous episode of COVID-19
• respiratory symptoms up to 14 days before the study
• history of systematic treatment with corticosteroids and/or immunosuppressant medications

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital

Istanbul, Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hamdi C Emeksiz, MD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: September 3, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 12, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

TU (1)