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Taking peoplePhase 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.

Plain-language title generated from the registry record
Registry title: Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A

Key facts

Where
Milan, ItalySee the site
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 Italy

  • Istituto San RaffaeleMilan, ItalyNot yet recruiting

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

Trial 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.

EU CTIS 2023-507348-35-00