Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Completed

CT.gov ID

NCT05620251

Collaborator

(none)

121

Enrollment

Location

9.3

Actual Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
type1diabetes	Diagnostic Test: Blood test

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.

Study Design

Study Type:

Observational

Actual Enrollment :

121 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 3, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Jun 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 infection-naive adolescents with type 1 diabetes	Diagnostic Test: Blood test Assessment of humoral immune response
COVID-19 infection-naive healthy controls	Diagnostic Test: Blood test Assessment of humoral immune response

Arm

Intervention/Treatment

COVID-19 infection-naive adolescents with type 1 diabetes

Diagnostic Test: Blood test

Assessment of humoral immune response

COVID-19 infection-naive healthy controls

Diagnostic Test: Blood test

Assessment of humoral immune response

Outcome Measures

Primary Outcome Measures

humoral immune response after first vaccine dose [28 days after first vaccine dose]
Levels of antibodies detected against SARSCoV2
humoral immune response after second vaccine dose [28 days after second vaccine dose]
Levels of antibodies detected against SARSCoV2

Secondary Outcome Measures

Adverse events [up to 28 days after first vaccine dose and up to 28 days after second vaccine dose]
type and number

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital	Istanbul	Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy	Turkey	34722