Anti-viral Action Against Type 1 Diabetes Autoimmunity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,252
- 试验地点
- 9
- 主要终点
- Persistent confirmed islet autoantibodies or type 1 diabetes
研究概览
简要总结
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:
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Previous hypersensitivity to the excipients of the vaccine.
- •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.
- •Likely poor compliance due to expected change in residency.
- •Diagnosis of diabetes prior to recruitment or randomisation
- •Current use of any other investigational drug
研究组 & 干预措施
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
- st dose at age 6.0 to 7.0 months
- nd dose at least 3 weeks through to 6 weeks after 1st dose
- rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)
Dose adjustment in case of COVID-19 infection.
干预措施: Comirnaty Injectable Product (Drug)
Placebo
0.9 % Sodium Chloride Solution (saline) for intramuscular injection Dosing: three doses
- st dose at age 6.0 to 7.0 months
- nd dose at least 3 weeks through to 6 weeks after 1st dose
- rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
Persistent confirmed islet autoantibodies or type 1 diabetes
时间窗: Through study completion, up to 6 years
The primary outcome is the elapsed time from first vaccination to the development of persistent confirmed islet autoantibodies or type 1 diabetes.
次要结局
- Persistent confirmed transglutaminase autoantibodies(Through study completion, up to 6 years)
- Type 1 diabetes(Through study completion, up to 6 years)
- Persistent confirmed multiple islet autoantibodies(Through study completion, up to 6 years)