Anti-viral Action Against Type 1 Diabetes Autoimmunity

September 22, 2025 updated by: Technical University of Munich

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2252

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
        • Contact:
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
        • Contact:
          • Kristina Casteels, Prof. Dr.
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80939
        • Recruiting
        • Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
        • Contact:
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30173
        • Recruiting
        • AUF DER BULT, Kinder- und Jugendkrankenhaus
        • Contact:
          • Olga Kordonouri, Prof. Dr.
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
        • Contact:
          • Reinhard Berner, Prof.Dr.
  • Sweden
      • Malmo, Sweden, 20213
        • Recruiting
        • Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
        • Contact:
          • Marcus Lundgren, Dr.
  • United Kingdom
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Birmingham Women's and Children's NHS Foundation Trust
        • Contact:
          • Renuka Dias
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
          • Loredana Marcovecchio, MD, PhD
      • Newcastle, United Kingdom
        • Recruiting
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
        • Contact:
          • Catherine Owen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Verum

Comirnaty® 3 µg Omicron XBB.1.5 or future new variant developments replacing current Comirnaty vaccines for children

Suspension for injection, for intramuscular use

  1. st dose at age 6.0 to 7.0 months
  2. nd dose at least 3 weeks through to 6 weeks after 1st dose
  3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)

Dose adjustment in case of COVID-19 infection.
Drug: Comirnaty Injectable Product
Vaccination
Other Names:
  • Comirnaty 3µg/dose for children for 6 month - 4 years
Placebo Comparator: Placebo

0.9 % Sodium Chloride Solution (saline) for intramuscular injection Dosing: three doses

  1. st dose at age 6.0 to 7.0 months
  2. nd dose at least 3 weeks through to 6 weeks after 1st dose
  3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)
Drug: Sodium Chloride 0.9% Inj
Vaccination
Other Names:
  • Solution for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent confirmed islet autoantibodies or type 1 diabetes
Time Frame: 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.
Through study completion, up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent confirmed multiple islet autoantibodies
Time Frame: Through study completion, up to 6 years
Elapsed time from first vaccination to persistent confirmed multiple islet autoantibodies;
Through study completion, up to 6 years
Type 1 diabetes
Time Frame: Through study completion, up to 6 years
Elapsed time from first vaccination to type 1 diabetes.
Through study completion, up to 6 years
Persistent confirmed transglutaminase autoantibodies
Time Frame: Through study completion, up to 6 years
Elapsed time from first vaccination to the development of persistent confirmed transglutaminase autoantibodies.
Through study completion, up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Universitaire Ziekenhuizen KU Leuven
Cambridge University Hospitals NHS Foundation Trust
Helmholtz Zentrum München
Newcastle-upon-Tyne Hospitals NHS Trust
Skane University Hospital
Birmingham Women's and Children's NHS Foundation Trust
Kinderkrankenhaus auf der Bult
University Hospital Carl Gustav Carus

Investigators

  • Principal Investigator: Anette-G. Ziegler, Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPPAD-05-AVAnT1A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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