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Taking people in AustriaPhase 4

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.

Key facts

Who runs it
Klinikum rechts der Isar der TU Muenchen AöR
Where
Vienna, AustriaSee the siteAlso in 5 other countries, 8 sites
Registry title
Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A
Status
Recruiting
Phase
Phase 4
People taking part
2,365 people, planned
Started
30 May 2024
Expected to end
1 Oct 2029
Type of study
Interventional
Record updated
22 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Where in Austria

Also in 5 other countries, 8 sites

  • Medical University of ViennaVienna, AustriaTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A
Plain-language title
COVID-19 vaccine study in children at high genetic risk of type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
22 October 2026