Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

NCT ID: NCT05620251

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-06-12

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.

Conditions

type1diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 infection-naive adolescents with type 1 diabetes

Blood test

Intervention Type: DIAGNOSTIC_TEST

Assessment of humoral immune response

COVID-19 infection-naive healthy controls

Blood test

Intervention Type: DIAGNOSTIC_TEST

Assessment of humoral immune response

Interventions

Blood test

Assessment of humoral immune response

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• aged between 12-18 years
• history of diabetes
• willingness to provide informed consent

• aged between 12-18 years
• good health
• no previous history of diabetes
• willingness to provide informed consent

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Hamdi Cihan Emeksiz

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamdi C Emeksiz, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Locations

Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital

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

Countries

Turkey (Türkiye)

Other Identifiers

2022/0190

Identifier Type: -

Identifier Source: org_study_id