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.
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