Anti-viral Action Against Type 1 Diabetes Autoimmunity

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months. The study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes. The primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Secondary objectives are: 1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood. 2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and 3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood. Further exploratory objectives are described in the study protocol. Study participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261). Eligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit). Randomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.

Key facts

Study ID

NCT06452654

Run by

Technical University of Munich

People needed

2252

Starts

2024-05-08

Expected to finish

2027-10-01

Last updated by the study team

2025-09-23

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• Previous hypersensitivity to the excipients of the vaccine.
• 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

Where it is running

• The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle, United Kingdom (enrolling)
• University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven — Leuven, Belgium (enrolling)
• Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich — Munich, Bavaria, Germany (enrolling)
• AUF DER BULT, Kinder- und Jugendkrankenhaus — Hanover, Lower Saxony, Germany (enrolling)
• Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden — Dresden, Saxony, Germany (enrolling)
• Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS — Malmö, Sweden (enrolling)
• Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom
• Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom
• Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria — Vienna, Austria

Full record on ClinicalTrials.gov

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