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Anti-viral action against type 1 diabetes autoimmunity: The GPPAD-AVAnT1A study protocol.
Contemp. Clin. Trails Comm. 44:101434 (2025)
Verlagsversion
Forschungsdaten
DOI
PMC
Viral infections in the first year of life are associated with islet autoimmunity and type 1 diabetes risk. The Anti-Viral Action against Type 1 Diabetes Autoimmunity (AVAnT1A)- study is a clinical phase IV investigator initiated, randomised, controlled, multicentre, primary prevention trial conducted to determine whether vaccination against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in children with elevated genetic risk. Additionally, it investigates the role of viral infections in the etiology of islet autoimmunity by intense surveillance within the first two years of life. Infants aged 3.00–4.00 months from Germany, Belgium, UK and Sweden are eligible if they have a >10 % expected risk to develop islet autoantibodies by age 6 years as determined by HLA DR/DQ genotype, polygenic risk score and family history of type 1 diabetes. A total of 2252 eligible children are randomized 1:1 to COVID-19 vaccine (Comirnaty® 3 μg Omicron XBB.1.5 or future new variants) or placebo (0.9 % Sodium Chloride) administered three times. Children are followed until the minimum age of 2.5 years and maximum age of 6 years. The intervention is accompanied by analyses of immune and metabolic parameters to determine changes induced by viral infections and to investigate mechanisms by which viral infection may lead to islet autoimmunity. The Sponsor is the Klinikum rechts der Isar, Technical University Munich. The study was approved by Clinical Trials Information System (CTIS, EU Trial number: 2023-507348-35-00) and by Integrated Research Application System (IRAS, IRAS-ID: 1009668).
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Publikationstyp
Artikel: Journalartikel
Dokumenttyp
Wissenschaftlicher Artikel
Schlagwörter
Covid-19 ; Infection ; Islet Autoimmunity ; Type 1 Diabetes ; Vaccination; Beta-cell Autoimmunity; Islet Autoimmunity; Respiratory-infections; Early-life; Risk; Children; Autoantigen; Autoantibodies; Identification; Disease
ISSN (print) / ISBN
2451-8654
e-ISSN
2451-8654
Zeitschrift
Contemporary clinical trials communications
Quellenangaben
Band: 44,
Artikelnummer: 101434
Verlag
Elsevier
Verlagsort
Amsterdam
Nichtpatentliteratur
Publikationen
Begutachtungsstatus
Peer reviewed
Institut(e)
Institute of Pancreatic Islet Research (IPI)
Institute of Diabetes Research (IDF)
Institute of Diabetes Research (IDF)
Förderungen
German Center for Diabetes Research (DZD e.V.)
Swedish Diabetes Foundation
EASD-Novo Nordisk Foundation Diabetes Prize for Excellence
Bavarian Ministry of Economic Affairs, Energy, and Technology, Germany
Helm-holtz Munich, German Research Center for Environmental Health, Germany
Leona M. and Harry B. Helmsley Charitable Trust (Helmsley)
Swedish Diabetes Foundation
EASD-Novo Nordisk Foundation Diabetes Prize for Excellence
Bavarian Ministry of Economic Affairs, Energy, and Technology, Germany
Helm-holtz Munich, German Research Center for Environmental Health, Germany
Leona M. and Harry B. Helmsley Charitable Trust (Helmsley)