INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Change in fasting residual β cell (C-peptide) function.
研究概览
简要总结
In a multicenter, prospective, randomized, controlled clinical trial to compare influenza vaccination and placebo in sustaining β cell function in early type 1 diabetes mellitus.
详细描述
Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. In theory, immunotherapies aimed at re-programming the immune system to avoid β cell destruction is a promising strategy to prevent T1D or delay onset of overt disease.
In this trial we test the hypothesis that influenza vaccination is superior to no influenza vaccination in sustaining β cell function in early T1D. Secondary outcome measures include change in autoantibodies directed against antigens present in the pancreatic islets, measures of severity of disease, change in inflammatory markers, and antibody titers against the four viruses included in the vaccine.
Despite improvements in care, T1D is a leading cause of debilitating complications and early death globally. Children with residual β cell function are at lower risk for severe hypoglycemia, have better diabetes regulation, and have lower insulin requirements compared to children without residual β cell function. Thus, a simple, cheap treatment to mitigate T1D is highly warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The following are masked in the study: Participant, Care Provider, Investigator, Outcomes Assessor.
The following are not masked: unblinded study nurses at participating sites randomizing participants in the eCRF system. The unblinded study nurses are not otherwise involved or participating in the study.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- •Written informed consent (parents, legal guardian).
排除标准
- •Influenza vaccination during the current influenza season.
- •Strong indication for influenza vaccination for non-diabetic disease.
- •Severe allergy to eggs or previous allergic reaction to influenza vaccine.
- •Suspicion of febrile illness or acute, ongoing infection.
- •Hypersensitivity to the active substances or ingredients of Vaxigrip Tetra or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
- •Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- •Inability to provide informed consent from a parent or legal guardian.
- •Age <7 or ≥18 years.
- •Previous randomization in the INVITED trial.
研究组 & 干预措施
Influenza vaccination
Influenza vaccine, 0.5 mL.
干预措施: Vaxigrip Tetra Sanofi Pasteur Europe (Biological)
Placebo
Placebo, 0.5 mL saline.
干预措施: Vaxigrip Tetra Sanofi Pasteur Europe (Biological)
结局指标
主要结局
Change in fasting residual β cell (C-peptide) function.
时间窗: 12 months
Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 12 months/ AUC 0-4 h, C-peptide, baseline)
次要结局
- Change in fasting residual β cell (C-peptide) function.(6 months.)
- Change in insulin requirements.(12 months.)
- Time-In-Range of blood glucose.(12 months.)
- Variation of blood glucose.(12 months.)
- Change in HbA1c(12 months.)
研究者
Ole Frøbert, MD, PhD
Professor
Aarhus University Hospital