Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2252 participants
INTERVENTIONAL
2024-05-08
2027-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Comirnaty Injectable Product
Vaccination
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)
Sodium Chloride 0.9% Inj
Vaccination
Interventions
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Comirnaty Injectable Product
Vaccination
Sodium Chloride 0.9% Inj
Vaccination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
3 Months
4 Months
ALL
Yes
Sponsors
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Helmholtz Zentrum München
INDUSTRY
University Hospital Carl Gustav Carus
OTHER
Kinderkrankenhaus auf der Bult
OTHER
Skane University Hospital
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Birmingham Women's and Children's NHS Foundation Trust
OTHER
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Anette-G. Ziegler
Role: PRINCIPAL_INVESTIGATOR
Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany
Locations
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Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
Vienna, , Austria
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
Leuven, , Belgium
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
Munich, Bavaria, Germany
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Lower Saxony, Germany
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, Germany
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
Malmo, , Sweden
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Kristina Casteels, Prof. Dr.
Role: primary
Olga Kordonouri, Prof. Dr.
Role: primary
Reinhard Berner, Prof.Dr.
Role: primary
Marcus Lundgren, Dr.
Role: primary
Renuka Dias
Role: primary
Loredana Marcovecchio, MD, PhD
Role: primary
Catherine Owen, PhD
Role: primary
Other Identifiers
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GPPAD-05-AVAnT1A
Identifier Type: -
Identifier Source: org_study_id
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