Anti-viral action against Type 1 diabetes autoimmunity

Phase 4

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN82491599
• Lead Sponsor: Klinikum rechts der Isar Technische Universitat

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Last Update Posted: 9 September 2024
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2252

Inclusion Criteria

1. Age between 3.00 and 4.00 months at the time of enrolment
2. A high genetic risk (>10%) to develop islet autoantibodies by age 6 years:
2.1. For children without a first-degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR3/DR4-DQ7 rs6901541 C/T genotype and an elevated sex-specific genetic risk score that is at the 98.75th centile, in other words identifies around 1.25% of newborns without a first-degree family history with type 1 diabetes.
2.2. For children with a first-degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, none of the following protective alleles: DRB1*1501, DQB1*0503, DRB1*1303, and a sex-specific genetic risk score >50th centile of the background population. These represent around 25% of children with a first-degree family history of type 1 diabetes.
3. Written informed consent signed by the custodial parent(s)

Exclusion Criteria

1. Previous hypersensitivity to the excipients of the vaccine. These include:
1.1. ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
1.2. 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
1.3. 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
1.4. Cholesterol
1.5. Trometamol
1.6. Trometamol hydrochloride
1.7. Sucrose
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The elapsed time from random treatment assignment to the development of persistent confirmed islet autoantibodies (evaluated through blood samples taken prior to receiving COVID-19 vaccination, at the time of the 3rd vaccination, then 3 monthly between the ages of 12 to 24 months, 6 monthly between the ages of 24 to 36 months, and then annually thereafter) or the development of type 1 diabetes (based on criteria defined by the American Diabetes Association)

Secondary Outcome Measures

Name	Time	Method
1. The elapsed time from random treatment assignment to the development of multiple islet autoantibodies, evaluated through blood samples taken prior to receiving COVID-19 vaccination, at the time of the 3rd vaccination, then 3 monthly between the ages of 12 to 24 months, 6 monthly between the ages of 24 to 36 months, and then annually thereafter<br>2. The elapsed time from random treatment assignment to the development of type 1 diabetes based on criteria defined by the American Diabetes Association<br>3. The elapsed time from random treatment assignment to the development of persistent confirmed transglutaminase antibodies, evaluated through blood samples taken 6 monthly between 12 and 36 months of age, and then annually thereafter