Anti-viral action against Type 1 diabetes autoimmunity

Klinikum rechts der Isar Technische Universitat0 个研究点目标入组 2,252 人开始时间: 2024年7月26日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•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)

•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.

发起方

Klinikum rechts der Isar Technische Universitat