Anti-viral action against Type 1 diabetes autoimmunityGPPAD-05-AVAnT1A
- Conditions
- Risk for Type 1 DiabetesMedDRA version: 20.0Level: HLTClassification code: 10012602Term: Diabetes mellitus (incl subtypes) Class: 10027433Therapeutic area: Health Care [N] - Environment and Public Health [N06]Therapeutic area: Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-507348-35-00
- Lead Sponsor
- Klinikum rechts der Isar der TU Muenchen AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2252
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)
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., Likely poor compliance due to expected change in residency., Diagnosis of diabetes prior to recruitment or randomisation, Current use of any other investigational drug, Previous hypersensitivity to the excipients of the vaccine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method