Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Condition: type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

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.
    

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.
    

Intervention name(s): Blood test
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of humoral immune response
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: type 1 diabetes; SARS-CoV-2; immunogenicity; antibody; covid-19; adolescents; vaccine; BNT162b2