Actively Recruiting
Anti-viral Action Against Type 1 Diabetes Autoimmunity in Children at Increased Genetic Risk Using COVID-19 Vaccination or Placebo
Led by Technical University of Munich · Updated on 2025-09-23
2252
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Technical University of Munich
Lead Sponsor
H
Helmholtz Zentrum München
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether giving COVID-19 vaccines to young children with a higher genetic risk of developing type 1 diabetes can lower the chance of developing this condition or related autoantibodies. This phase 4 trial involves children identified through genetic risk screening. The study aims to see if vaccination starting from 6 months of age can reduce the occurrence of islet autoantibodies, type 1 diabetes, and celiac disease-related autoantibodies during childhood. Children enrolled between 3 and 4 months old will be randomly assigned to receive either the Comirnaty 3 microgram Omicron XBB.1.5 vaccine (or updated variant vaccines) or a placebo (saline solution). They will receive three intramuscular doses starting at age 6 to 7 months, with the second dose given 3 to 6 weeks after the first, and the third dose at least 8 weeks after the second, around 8.5 to 11 months of age. Dose adjustments may be made if the child develops COVID-19 infection. During the study, participants will be monitored for up to 6 years to track the presence of persistent islet autoantibodies, type 1 diabetes diagnosis, and celiac disease-related autoantibodies. Parent consent is required before enrollment, and children will be regularly assessed to evaluate the vaccine's impact on these outcomes. The study will also observe safety and adherence throughout the follow-up period.
CONDITIONS
Brief Title
Anti-viral Action Against Type 1 Diabetes Autoimmunity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages between 3.00 and 4.00 months at the time of enrollment
- High genetic risk (>10%) to develop islet autoantibodies by age 6 years based on HLA DR/DQ genotype, polygenic risk score, and family history of type 1 diabetes
- Written informed consent signed by the custodial parent(s)
You will not qualify if you...
- Previous hypersensitivity to vaccine ingredients
- Any medical condition, disease, or treatment affecting assessments or safe participation, including immune deficiencies or immune suppression
- Likely poor compliance due to expected change in residency
- Diagnosis of diabetes prior to recruitment or randomization
- Current use of any other investigational drug
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 months from first dose at age 6 to 7 months to third dose around age 8.5 to 11 months
Participants receive three doses of either the Comirnaty vaccine or a placebo injection to assess the prevention of type 1 diabetes autoimmunity.
3 vaccination visits (in-person)
Duration - Up to 6 years
Participants are monitored for up to 6 years to assess the development of islet autoantibodies and type 1 diabetes.
Trial Site Locations
Total: 9 locations
1
Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
Vienna, Austria, 1090
Not Yet Recruiting
2
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium, 3000
Actively Recruiting
3
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
Munich, Bavaria, Germany, 80939
Actively Recruiting
4
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Lower Saxony, Germany, 30173
Actively Recruiting
5
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
6
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
Malmö, Sweden, 20213
Actively Recruiting
7
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
Not Yet Recruiting
8
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Not Yet Recruiting
9
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Actively Recruiting
Research Team
A
Anette-G. Ziegler, Prof. Dr.
P
Peter Achenbach, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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