TY - JOUR
T1 - Anti-viral action against type 1 diabetes autoimmunity
T2 - The GPPAD-AVAnT1A study protocol
AU - GPPAD Study Group
AU - Hummel, Sandra
AU - Käßl, Alexandra
AU - Arnolds, Stefanie
AU - Achenbach, Peter
AU - Berner, Reinhard
AU - Casteels, Kristina
AU - Hyöty, Heikki
AU - Kordonouri, Olga
AU - Larsson, Helena Elding
AU - Lundgren, Markus
AU - Marcovecchio, M. Loredana
AU - Owen, Catherine
AU - Pfirrmann, Markus
AU - Robson, Steve
AU - Szadkowska, Agnieszka
AU - Szypowska, Agnieszka
AU - Tree, Timothy
AU - Weiss, Andreas
AU - Ziegler, Anette Gabriele
AU - Bonifacio, Ezio
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/4
Y1 - 2025/4
N2 - 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).
AB - 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).
KW - COVID-19
KW - Infection
KW - Islet autoimmunity
KW - Type 1 diabetes
KW - vaccination
U2 - 10.1016/j.conctc.2025.101434
DO - 10.1016/j.conctc.2025.101434
M3 - Article
AN - SCOPUS:85215846365
SN - 2451-8654
VL - 44
JO - Contemporary clinical trials communications
JF - Contemporary clinical trials communications
M1 - 101434
ER -
