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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05620251
Enrollment
121
Registered
2022-11-17
Start date
2021-09-03
Completion date
2022-06-12
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type1diabetes

Keywords

type 1 diabetes, SARS-CoV-2, immunogenicity, antibody, covid-19, adolescents, vaccine, BNT162b2

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.

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.

Interventions

DIAGNOSTIC_TESTBlood test

Assessment of humoral immune response

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
humoral immune response after first vaccine dose28 days after first vaccine doseLevels of antibodies detected against SARSCoV2
humoral immune response after second vaccine dose28 days after second vaccine doseLevels of antibodies detected against SARSCoV2

Secondary

MeasureTime frameDescription
Adverse eventsup to 28 days after first vaccine dose and up to 28 days after second vaccine dosetype and number

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026