Detection of enterovirus RNA in peripheral blood mononuclear cells correlates with the presence of the predisposing allele of the type 1 diabetes risk gene IFIH1 and with disease stage

Sioofy-Khojine, A-B; Richardson, SJ; Locke, JM; Oikarinen, S; Nurminen, N; Laine, A-P; Downes, K; Lempainen, J; Todd, JA; Veijola, R; Ilonen, J; Knip, M; Morgan, NG; Hyöty, H; Peakman, M; Eichmann, M

COVID-19 Collection

Journal article

Detection of enterovirus RNA in peripheral blood mononuclear cells correlates with the presence of the predisposing allele of the type 1 diabetes risk gene IFIH1 and with disease stage

Abstract:: 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)

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Sioofy-Khojine, A.-B., Richardson, S. J., Locke, J. M., Oikarinen, S., Nurminen, N., Laine, A.-P., Downes, K., Lempainen, J., Todd, J. A., Veijola, R., Ilonen, J., Knip, M., Morgan, N. G., Hyöty, H., Peakman, M., & Eichmann, M. (2022). Detection of enterovirus RNA in peripheral blood mononuclear cells correlates with the presence of the predisposing allele of the type 1 diabetes risk gene IFIH1 and with disease stage. Diabetologia, 65(10), 1701–1709.

MLA Style

Sioofy-Khojine, A-B, et al. “Detection of Enterovirus RNA in Peripheral Blood Mononuclear Cells Correlates with the Presence of the Predisposing Allele of the Type 1 Diabetes Risk Gene IFIH1 and with Disease Stage.” Diabetologia, vol. 65, no. 10, 2022, pp. 1701–09.

Chicago Style

Sioofy-Khojine, A-B, SJ Richardson, JM Locke, et al. 2022. “Detection of Enterovirus RNA in Peripheral Blood Mononuclear Cells Correlates with the Presence of the Predisposing Allele of the Type 1 Diabetes Risk Gene IFIH1 and with Disease Stage.” Diabetologia 65 (10): 1701–9.
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