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 OmicronXBB.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 1diabetes.The primary objective is to determine whether vaccination of children with elevatedgenetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces thecumulative 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 riskof 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.
Not Provided
Drug: Comirnaty Injectable Product
Vaccination
Other Name: Comirnaty 3µg/dose for children for 6 month - 4 years
Drug: Sodium Chloride 0.9% Inj
Vaccination
Other Name: Solution for Injection
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
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
Leuven 2792482, Belgium
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
Munich 2867714, Bavaria 2951839, Germany
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover 2910831, Lower Saxony 2862926, Germany
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
Dresden 2935022, Saxony 2842566, Germany
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
Malmo 2692969, Sweden
Birmingham Women's and Children's NHS Foundation Trust
Birmingham 2655603, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge 2653941, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle 6695976, United Kingdom
Anette-G. Ziegler, Prof. Dr.
+49-89-3187 - 2896
anettegabriele.ziegler@helmholtz-munich.de
Peter Achenbach, Prof. Dr.
+49-89-3187 - 2896
peter.achenbach@helmholtz-munich.de
Anette-G. Ziegler, Principal Investigator
Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany