Clinical trial NCT06452654: Anti-viral Action Against Type 1 Diabetes Autoimmunity
Official title: Anti-viral Action Against Type 1 Diabetes Autoimmunity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Helmholtz Zentrum München
name: University Hospital Carl Gustav Carus
name: Kinderkrankenhaus auf der Bult
name: Skane University Hospital
name: Universitaire Ziekenhuizen KU Leuven
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: Birmingham Women's and Children's NHS Foundation Trust
First posted: 2024-06-11
Enrollment: 2252
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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 criteria: 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 outcomes:
measure: Persistent confirmed islet autoantibodies or type 1 diabetes
timeFrame: Through study completion, up to 6 years
Secondary outcomes:
measure: Persistent confirmed multiple islet autoantibodies
timeFrame: Through study completion, up to 6 years
measure: Type 1 diabetes
timeFrame: Through study completion, up to 6 years
measure: Persistent confirmed transglutaminase autoantibodies
timeFrame: Through study completion, up to 6 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
city: Munich
country: Germany
facility: Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
state: Bavaria
city: Hanover
country: Germany
facility: AUF DER BULT, Kinder- und Jugendkrankenhaus
state: Niedersachsen
city: Dresden
country: Germany
facility: Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
state: Sachsen
city: Malmö
country: Sweden
facility: Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany
name: Anette-G. Ziegler
role: PRINCIPAL_INVESTIGATOR
References: