Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05620251
Other study ID # 2022/0190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2021
Est. completion date June 12, 2022

Study information

Verified date November 2022
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date June 12, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Blood test
Assessment of humoral immune response

Locations

Country Name City State
Turkey Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital Istanbul Egitim Mah. Fahrettin Kerim Gökay Caddesi, Kadiköy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary humoral immune response after first vaccine dose Levels of antibodies detected against SARSCoV2 28 days after first vaccine dose
Primary humoral immune response after second vaccine dose Levels of antibodies detected against SARSCoV2 28 days after second vaccine dose
Secondary Adverse events type and number up to 28 days after first vaccine dose and up to 28 days after second vaccine dose
See also
  Status Clinical Trial Phase
Completed NCT03886974 - Transition to Adult Care in Type 1 Diabetes
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Active, not recruiting NCT05078658 - Low-carbohydrate Diet in Children With Type 1 Diabetes N/A
Not yet recruiting NCT06018324 - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT03177096 - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes N/A
Not yet recruiting NCT06418269 - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes N/A
Completed NCT04172077 - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting NCT04950634 - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed NCT04450745 - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients N/A
Completed NCT03165786 - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes N/A
Terminated NCT04028960 - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase Phase 2
Recruiting NCT05324488 - Diabetes Registry Graz for Biomarker Research
Completed NCT02984709 - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes N/A
Completed NCT02984514 - Brown Adipose Tissue in Type 1 Diabetes N/A
Recruiting NCT06372392 - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps N/A
Recruiting NCT03311516 - New Insulin Therapy by Multiwave Bolus N/A
Recruiting NCT05973799 - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes N/A
Completed NCT03711656 - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques N/A
Recruiting NCT05737654 - The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life N/A