Vaccination to prevent type 1 diabetes in at-risk children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.