type1diabetesNCT05620251
Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
An observational study of type1diabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- type1diabetes
- What is being tested?
- Blood test
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2021to 12 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: SARSCoV2-naive adolescents with type 1 diabetes and SARSCoV2-naive healthy control adolescents who will undergo blood sampling for testing levels of antibodies against SARSCoV2 after SARSCoV2 vaccination will be consecutively included in this prospective study.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University, Professor Doctor Suleyman Yalcin city Hospital
Istanbul, Eğitim Mah. Fahrettin Kerim Gökay Caddesi, Kadıköy, 34722
About this study
Official title: Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study
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.
Read the 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
- Being tested
- Blood test
- Keywords
- type 1 diabetes, SARS-CoV-2, immunogenicity, antibody, covid-19, adolescents, vaccine, BNT162b2
- Medical subject headings
- Diabetes Mellitus, Type 1, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Assessment of humoral immune response
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection-naive adolescents with type 1 diabetes | Not described Receives: Diagnostic Test: Blood test | |
| COVID-19 infection-naive healthy controls | Not described Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
humoral immune response after first vaccine dose
Levels of antibodies detected against SARSCoV2
Measured: 28 days after first vaccine dose
humoral immune response after second vaccine dose
Levels of antibodies detected against SARSCoV2
Measured: 28 days after second vaccine dose
Secondary outcomes (1)
Adverse events
type and number
Measured: up to 28 days after first vaccine dose and up to 28 days after second vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start3 Sep 2021
- Primary completion28 Feb 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdi Cihan Emeksiz, Istanbul Medeniyet University
- Investigators
- Hamdi C Emeksiz, MD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620251
- Sponsor's protocol ID
- 2022/0190
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05620251
- Acronym / sponsor ID
- 2022/0190
- Conditions
- type1diabetes
- Keywords
- type 1 diabetes, SARS-CoV-2, immunogenicity, antibody, covid-19, adolescents, vaccine, BNT162b2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection-naive adolescents with type 1 diabetes | – | Diagnostic Test: Blood test |
| COVID-19 infection-naive healthy controls | – | Diagnostic Test: Blood test |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- SARSCoV2-naive adolescents with type 1 diabetes and SARSCoV2-naive healthy control adolescents who will undergo blood sampling for testing levels of antibodies against SARSCoV2 after SARSCoV2 vaccination will be consecutively included in this prospective study.
Key inclusion criteria (7 listed)
- aged between 12-18 years
- history of diabetes
- willingness to provide informed consent
- aged between 12-18 years
- good health
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAssessment of humoral immune response | Diagnostic test | COVID-19 infection-naive adolescents with type 1 diabetes, COVID-19 infection-naive healthy controls |
Primary outcome
humoral immune response after first vaccine dose
Time frame: 28 days after first vaccine dose
Levels of antibodies detected against SARSCoV2
humoral immune response after second vaccine dose
Time frame: 28 days after second vaccine dose
Levels of antibodies detected against SARSCoV2
1 secondary outcome
Adverse events
Time frame: up to 28 days after first vaccine dose and up to 28 days after second vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdi C Emeksiz, MD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of type1diabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
humoral immune response after first vaccine dose (time frame: 28 days after first vaccine dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.