Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT05620251
Recruitment Status : Completed
First Posted : November 17, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Hamdi Cihan Emeksiz, Istanbul Medeniyet University

Study Description
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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.

Condition or disease Intervention/treatment
type1diabetes Diagnostic Test: Blood test

Detailed Description:

Having either form of diabetes as a comorbidity has been implicated as a risk factor for severe COVID-19. Therefore, vaccination against COVID-19 has been highly recommended for people with diabetes. However, since diabetes is associated with persistent and profound impairments in both innate and acquired immunity, whether the immune system of people with diabetes will be able to mount an adequate antibody (ab) response following COVID-19 vaccination has remained in question. Some studies have reported that adults with diabetes develop an inadequate immune response to hepatitis B vaccines, whereas less consistent results have been reported for varicella-zoster and influenza vaccines. Likewise, certain pediatric studies have found that serum ab titers against hepatitis B surface antigen and pneumococcal antigens were lower in children with type 1 diabetes than in controls following hepatitis B vaccine and unconjugated pneumococcal polysaccharide vaccine administration. In this context, concerns about the effectiveness of COVID-19 vaccines in people with diabetes have led to the investigation of their immunogenicity after vaccination against COVID-19.

Thus far, few studies have explored the ab response of people with diabetes following COVID-19 vaccination. In the majority of studies conducted, the seroconversion rates of people with diabetes were found to be lower than those of age-matched healthy controls. Nonetheless, the majority of the diabetic people included in these studies were still able to elicit a strong ab response. However, most of these studies only enrolled adults with type 2 diabetes. The ab response to COVID-19 vaccination in a pediatric cohort with type 1 diabetes has not been investigated. Thus, in this single-centered prospective observational study, the investigators aimed to analyze the ab response to a widely used and effective mRNA (messenger ribonucleic acid)-based SARS-CoV-2 vaccine, BNT162b2, in adolescents with type 1 diabetes compared to that of healthy controls and the factors associated with that response.

Study Design
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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study
Actual Study Start Date : September 3, 2021
Actual Primary Completion Date : February 28, 2022
Actual Study Completion Date : June 12, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
COVID-19 infection-naive adolescents with type 1 diabetes Diagnostic Test: Blood test
Assessment of humoral immune response
COVID-19 infection-naive healthy controls Diagnostic Test: Blood test
Assessment of humoral immune response


Outcome Measures
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Primary Outcome Measures :
  1. humoral immune response after first vaccine dose [ Time Frame: 28 days after first vaccine dose ]
    Levels of antibodies detected against SARSCoV2

  2. humoral immune response after second vaccine dose [ Time Frame: 28 days after second vaccine dose ]
    Levels of antibodies detected against SARSCoV2


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: up to 28 days after first vaccine dose and up to 28 days after second vaccine dose ]
    type and number


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria for adolescents with type 1 diabetes:

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

Exclusion Criteria for adolescents with type 1 diabetes:

  • 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

Inclusion Criteria for controls:

  • aged between 12-18 years
  • good health
  • no previous history of diabetes
  • willingness to provide informed consent

Exclusion Criteria for controls:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05620251


Locations
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Turkey
Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital
Istanbul, Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy, Turkey, 34722
Sponsors and Collaborators
Istanbul Medeniyet University
Investigators
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Principal Investigator: Hamdi C Emeksiz, MD Istanbul Medeniyet University
More Information
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Responsible Party: Hamdi Cihan Emeksiz, associate professor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT05620251    
Other Study ID Numbers: 2022/0190
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamdi Cihan Emeksiz, Istanbul Medeniyet University:
type 1 diabetes
SARS-CoV-2
immunogenicity
antibody
 covid-19
adolescents
vaccine
BNT162b2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases