Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A
Key facts
- Where
- Dresden, Hanover és Munich, NémetországSee the 3 sites
- Phase
- 4. fázis
Where in Németország
- Technische Universität DresdenDresden, NémetországTaking people
- Hannoversche KinderheilanstaltHanover, NémetországTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországTaking 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?
Trial details
- Who runs it
- Klinikum rechts der Isar der TU Muenchen AöR
- Trial code
- EU 2023-507348-35-00
- Record updated
- 2026. október 22.
- 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
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.