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Recruiting NCT06452654

Anti-viral Action Against Type 1 Diabetes Autoimmunity

Phase IV Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comirnaty Injectable Product, Sodium Chloride 0.9% Inj.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 3 months — 4 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, Germany, Sweden, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Comirnaty Injectable Product
    Vaccination
  • Drug Sodium Chloride 0.9% Inj
    Vaccination

Primary outcome measures

  • Persistent confirmed islet autoantibodies or type 1 diabetes [Time frame: Through study completion, up to 6 years]
Secondary outcome measures (3)
  • Persistent confirmed multiple islet autoantibodies [Time frame: Through study completion, up to 6 years]
  • Type 1 diabetes [Time frame: Through study completion, up to 6 years]
  • Persistent confirmed transglutaminase autoantibodies [Time frame: Through study completion, up to 6 years]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Germany · 3 centers
  • Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Researc — Munich
  • AUF DER BULT, Kinder- und Jugendkrankenhaus — Hanover
  • Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, — Dresden
United Kingdom · 3 centers
  • Birmingham Women's and Children's NHS Foundation Trust — Birmingham
  • Cambridge University Hospitals NHS Foundation Trust — Cambridge
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle
Austria · 1 center
  • Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürte — Vienna
Belgium · 1 center
  • University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven — Leuven
Sweden · 1 center
  • Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS — Malmö

Identifiers

NCT: NCT06452654 · GPPAD-05-AVAnT1A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗