Anti-viral Action Against Type 1 Diabetes Autoimmunity

NCT06452654 | Recruiting Phase 4 DMC

• 1 other identifier: GPPAD-05-AVAnT1A
• Study Type: interventional
• Target: 2,252
• Locations: 5 countries
• Sites: 9

Brief 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. 1.to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
2. 2.to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and
3. 3.to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes; T1D; Diabetes mellitus; Autoantigen; Prevention; at risk for developing type 1 diabetes; Juvenile diabetes; Autoimmune diabetes; Corona; COVID-19; Viral infection; Viral infection surveillance; Immune response; Metabolism

Outcome Measures

Primary Outcomes (1)

• Persistent confirmed islet autoantibodies or type 1 diabetes

  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 Outcomes (3)

• Persistent confirmed multiple islet autoantibodies

  Through study completion, up to 6 years

• Type 1 diabetes

  Through study completion, up to 6 years

• Persistent confirmed transglutaminase autoantibodies

  Through study completion, up to 6 years

Study Arms (2)

Verum

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Comirnaty Injectable Product DRUG

Vaccination

Also known as: Comirnaty 3µg/dose for children for 6 month - 4 years

Verum

Sodium Chloride 0.9% Inj DRUG

Vaccination

Also known as: Solution for Injection

Placebo

Eligibility Criteria

• Age: 3 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

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

Study Sites (9)

Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria

Vienna, 1090, Austria

NOT YET RECRUITING

University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven

Leuven, 3000, Belgium

RECRUITING

Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich

Munich, Bavaria, 80939, Germany

RECRUITING

AUF DER BULT, Kinder- und Jugendkrankenhaus

Hanover, Lower Saxony, 30173, Germany

RECRUITING

Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS

Malmo, 20213, 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; COVID-19; Virus Diseases

Interventions

BNT162 Vaccine; Sodium Chloride; Solutions; Injections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Anette-G. Ziegler

  Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anette-G. Ziegler, Prof. Dr.

CONTACT

+49-89-3187; anettegabriele.ziegler@helmholtz-munich.de

Peter Achenbach, Prof. Dr.

CONTACT

+49-89-3187; peter.achenbach@helmholtz-munich.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 11, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

SE (1); DE (3); GB (3); AU (1); BE (1)