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Hummel, S. ; Käßl, A. ; Arnolds, S. ; Achenbach, P. ; Berner, R.* ; Casteels, K.* ; Hyöty, H.* ; Kordonouri, O.* ; Larsson, H.E.* ; Lundgren, M.* ; Marcovecchio, M.L.* ; Owen, C.* ; Pfirrmann, M.* ; Robson, S.C.* ; Szadkowska, A.* ; Szypowska, A.* ; Tree, T.* ; Weiss, A. ; Ziegler, A.-G. ; Bonifacio, E.

Anti-viral action against type 1 diabetes autoimmunity: The GPPAD-AVAnT1A study protocol.

Contemp. Clin. Trails Comm. 44:101434 (2025)
Publ. Version/Full Text Research data DOI PMC
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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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Publication type Article: Journal article
Document type Scientific Article
Keywords Covid-19 ; Infection ; Islet Autoimmunity ; Type 1 Diabetes ; Vaccination; Beta-cell Autoimmunity; Islet Autoimmunity; Respiratory-infections; Early-life; Risk; Children; Autoantigen; Autoantibodies; Identification; Disease
Language english
Publication Year 2025
HGF-reported in Year 2025
ISSN (print) / ISBN 2451-8654
e-ISSN 2451-8654
Journal Contemporary clinical trials communications
Quellenangaben Volume: 44, Issue: , Pages: , Article Number: 101434 Supplement: ,
Publisher Elsevier
Publishing Place Amsterdam
Reviewing status Peer reviewed
Institute(s) Institute of Pancreatic Islet Research (IPI)
Institute of Diabetes Research (IDF)
POF-Topic(s) 90000 - German Center for Diabetes Research
30201 - Metabolic Health
Research field(s) Helmholtz Diabetes Center
PSP Element(s) G-502600-006
G-502100-001
G-508800-010
Grants 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)
DOI 10.1016/j.conctc.2025.101434
WOS ID 001411493600001
Scopus ID 85215846365
PubMed ID 39916680
Erfassungsdatum 2025-03-26
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