Vaccination to prevent type 1 diabetes in at-risk children
Anti-viral Action Against Type 1 Diabetes Autoimmunity
This study is testing if giving a COVID-19 vaccine to young children at high risk for type 1 diabetes can help prevent the disease from developing.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2252 (estimated) |
| Ages | 3 Months to 4 Months |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 9 sites (Vienna and 8 other locations) |
| Trial ID | NCT06452654 on ClinicalTrials.gov |
What this trial studies
This phase 4 clinical trial aims to enroll 2252 children at increased genetic risk for type 1 diabetes, randomly assigning them to receive either a COVID-19 vaccine or a placebo starting at 6 months of age. The primary goal is to assess whether vaccination can reduce the incidence of islet autoantibodies or type 1 diabetes in childhood. Secondary objectives include evaluating the impact of vaccination on multiple islet autoantibodies and the overall incidence of type 1 diabetes. The study is conducted across multiple centers in various countries, emphasizing a rigorous, controlled approach to primary prevention.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3 to 4 months with a high genetic risk for type 1 diabetes.
Not a fit: Patients who have already been diagnosed with diabetes or have conditions that compromise their immune system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the risk of developing type 1 diabetes in genetically predisposed children.
How similar studies have performed: While the approach of using vaccination for prevention in this context is novel, similar studies have shown promise in other areas of autoimmune disease prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages between 3.00 and 4.00 months at the time of enrollment. 2. A high genetic risk (\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status. 3. Written informed consent signed by the custodial parent(s). Exclusion Criteria: 1. Previous hypersensitivity to the excipients of the vaccine. 2. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression. 3. Likely poor compliance due to expected change in residency. 4. Diagnosis of diabetes prior to recruitment or randomisation 5. Current use of any other investigational drug
Where this trial is running
Vienna and 8 other locations
- Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria — Vienna, Austria (Not_yet_recruiting)
- University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven — Leuven, Belgium (Recruiting)
- Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich — Munich, Bavaria, Germany (Recruiting)
- AUF DER BULT, Kinder- und Jugendkrankenhaus — Hanover, Lower Saxony, Germany (Recruiting)
- Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden — Dresden, Saxony, Germany (Recruiting)
- Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS — Malmö, Sweden (Recruiting)
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom (Not_yet_recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Not_yet_recruiting)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Anette-G. Ziegler — Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany
- Study coordinator: Anette-G. Ziegler, Prof. Dr.
- Email: anettegabriele.ziegler@helmholtz-munich.de
- Phone: +49-89-3187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.