Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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type1diabetes

Intervention / Treatment
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* Diagnostic Test: Blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infection-naive adolescents with type 1 diabetes<br> | Diagnostic Test: Blood test<br>* Assessment of humoral immune response<br>|
| COVID-19 infection-naive healthy controls<br> | Diagnostic Test: Blood test<br>* Assessment of humoral immune response<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, SARS-CoV-2, immunogenicity, antibody, covid-19, adolescents, vaccine, BNT162b2