Anti-viral Action Against Type 1 Diabetes Autoimmunity

NCT06452654 · tracked via the Priya Life Science Germany tracker

Sponsor

Technical University of Munich

Phase

Phase 4

Started

2024-05-08

Last updated

2025-09-23

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Comirnaty Injectable ProductSodium Chloride 0.9% Inj →

Comirnaty Injectable Product: Vaccination

Sodium Chloride 0.9% Inj: Vaccination

Study summary

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.

Eligibility

Sex

ALL

Min age

3 Months

Max age

4 Months

Healthy volunteers

Accepted

Inclusion Criteria: 1. Ages between 3.00 and 4.00 months at the time of enrollment. 2. 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. 3. Written informed consent signed by the custodial parent(s). Exclusion Criteria: 1. Previous hypersensitivity to the excipients of the vaccine. 2. 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. 3. Likely poor compliance due to expected change in residency. 4. Diagnosis of diabetes prior to recruitment or randomisation 5. Current use of any other investigational drug

Primary outcome measure(s)

Persistent confirmed islet autoantibodies or type 1 diabetes — Through study completion, up to 6 years
The primary outcome is the elapsed time from first vaccination to the development of persistent confirmed islet autoantibodies or type 1 diabetes.

Trial sites (9)

Facility	City	Region	Status
Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria	Vienna	Austria	Not Yet Recruiting
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven	Leuven	Belgium	Recruiting
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich	Munich	Bavaria	Recruiting
AUF DER BULT, Kinder- und Jugendkrankenhaus	Hanover	Lower Saxony	Recruiting
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden	Dresden	Saxony	Recruiting
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS	Malmö	Sweden	Recruiting
Birmingham Women's and Children's NHS Foundation Trust	Birmingham	United Kingdom	Not Yet Recruiting
Cambridge University Hospitals NHS Foundation Trust	Cambridge	United Kingdom	Not Yet Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle	United Kingdom	Recruiting

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A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06452654 on ClinicalTrials.gov ↗ ← All trials in Germany