COVID-19 vaccine study in children at high genetic risk of type 1 diabetes
Tests whether COVID-19 vaccination in children with high genetic risk reduces type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Anti-viral action against Type 1 diabetes autoimmunity
GPPAD-05-AVAnT1A
Key facts
- Where
- Dresden, Hanover, and Munich, GermanySee the 3 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies aged 3 to 4 months with a high genetic risk of type 1 diabetes. It tests COVID-19 vaccination from 6 months of age.
- Age
- 3.00 to 4.00 months at enrollment
- Sex
- All sexes can join.
- Disease stage
- No diabetes diagnosis before joining. A high genetic risk (>10%) of developing islet autoantibodies by age 6 years.
- Biomarker or test result
- High genetic risk (>10%) to develop islet autoantibodies by age 6 years, based on an HLA DR/DQ genotype, a polygenic risk score and a first-degree family history of type 1 diabetes.
Main reasons for not taking part
- Immune deficiency, or a condition or treatment that weakens the immune system
- Any condition or treatment that may interfere with the study or make taking part unsafe
- Diabetes diagnosed before recruitment or randomisation
- Current use of another investigational drug
- Earlier allergic reaction to an ingredient of the vaccine
Read by machine on 9 November 2026.
Where in Germany
- Technische Universität DresdenDresden, GermanyTaking people
- Hannoversche KinderheilanstaltHanover, GermanyTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Klinikum rechts der Isar der TU Muenchen AöR
- Trial code
- EU 2023-507348-35-00
- Record updated
- 22 October 2026
- Original description
To determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in child-hood.Read full original descriptionShow less
Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A
To determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in child-hood.
Inclusion: Ages between 3.00 and 4.00 months at the time of enrollment; 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; Written informed consent signed by the custodial parent(s).
Exclusion: 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; Diagnosis of diabetes prior to recruitment or randomisation; Current use of any other investigational drug; Previous hypersensitivity to the excipients of the vaccine; Likely poor compliance due to expected change in residency.