2023-507348-35-00RecruitingPhase 4
Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2365 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- 30 May 2024
- Lead sponsor
- Klinikum rechts der Isar der TU Muenchen AöR
- Diseases
- Type 1 diabetes
- EU CT number
- 2023-507348-35-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2365
- 9 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Likely poor compliance due to expected change in residency.
Who the study is looking for
- 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)
Age in the registry: - to 17 years · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Technische Universität Dresden | Dresden | Germany | Recruiting |
| Hannoversche Kinderheilanstalt | Hanover | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR | Munich | Germany | Recruiting |
| Istituto San Raffaele | Milan | Italy | Not yet recruiting |
| Clinical Trials Umed Sp. z o.o. | Lodz | Poland | Withdrawn |
| Warszawski Uniwersytet Medyczny | Warsaw | Poland | Withdrawn |
| Region Skane Skanes Universitetssjukhus | Malmo | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.