Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: type1diabetes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Turkey
  • Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy
    • Istanbul, Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy, Turkey, 34722
      • Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	type and number	up to 28 days after first vaccine dose and up to 28 days after second vaccine dose

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: Hamdi C Emeksiz, MD, İstanbul medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): June 12, 2022

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; antibody; adolescents; immunogenicity; covid-19; type 1 diabetes; BNT162b2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2022/0190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No