Anti-viral Action Against Type 1 Diabetes Autoimmunity

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 4 months
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Austria
Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
NOT_YET_RECRUITING
Vienna
Belgium
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
RECRUITING
Leuven
Germany
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
RECRUITING
Dresden
AUF DER BULT, Kinder- und Jugendkrankenhaus
RECRUITING
Hanover
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
RECRUITING
Munich
Sweden
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
RECRUITING
Malmo
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
Cambridge University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Cambridge
The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle
Contact Information
Primary
Anette-G. Ziegler, Prof. Dr.
anettegabriele.ziegler@helmholtz-munich.de
+49-89-3187
Backup
Peter Achenbach, Prof. Dr.
peter.achenbach@helmholtz-munich.de
+49-89-3187
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2027-10
Participants
Target number of participants: 2252
Treatments
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.
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)
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Carl Gustav Carus, Newcastle-upon-Tyne Hospitals NHS Trust, Kinderkrankenhaus auf der Bult, Cambridge University Hospitals NHS Foundation Trust, Universitaire Ziekenhuizen KU Leuven, Birmingham Women's and Children's NHS Foundation Trust, Helmholtz Zentrum München, Skane University Hospital
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov

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