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Completed

NCT Number: NCT05620251

Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Diagnostic Test

Assessment of humoral immune response

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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