Anti-viral Action Against Type 1 Diabetes Autoimmunity

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Anti-viral Action Against Type 1 Diabetes Autoimmunity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452654
• Other study ID #: GPPAD-05-AVAnT1A
• Status: Recruiting
• Phase: Phase 4
• Start date: May 8, 2024
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: Technical University of Munich
• Contact: Anette-G. Ziegler, Prof. Dr.
• Phone: +49-89-3187
• Email: anettegabriele.ziegler[@]helmholtz-munich.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2252
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Comirnaty Injectable Product
Vaccination
• Sodium Chloride 0.9% Inj
Vaccination

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven	Leuven
Germany	Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden	Dresden	Sachsen
Germany	AUF DER BULT, Kinder- und Jugendkrankenhaus	Hanover	Niedersachsen
Germany	Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich	Munich	Bavaria
Sweden	Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS	Malmö

Sponsors (6)

Lead Sponsor	Collaborator
Technical University of Munich	Helmholtz Zentrum München, Kinderkrankenhaus auf der Bult, Skane University Hospital, Universitaire Ziekenhuizen KU Leuven, University Hospital Carl Gustav Carus

Countries where clinical trial is conducted

Belgium,  Germany,  Sweden, 

Outcome

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