DIAPREV-IT: A clinical study evaluating the safety of the diabetes vaccine Diamyd® and if it can delay or stop the process leading to type 1 diabetes in children at high risk of developing the disease.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Children from four (4) years of age and participating in DiPiS, TEDDY or Trial Net.
2.Positive GAD65Ab (>35) and at least one additional type 1 diabetes-associated autoantibody (IA-2Ab >5, ZnT8R/W/Q/A Ab>72 or IAA>0,8).
3.Written informed consent from the child and the child’s parents or legal acceptable representative(s) according to local regulations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
2.Diabetes.
3.Treatment with any oral or injected anti-diabetic medications.
4.Significantly abnormal hematology results at screening.
5.Clinically significant history of acute reaction to vaccines or other drugs.
6.Treatment with any vaccine, other than influenza, within one month prior to the first dose of the study drug or planned treatment with vaccine up to two months after the last injection with the study drug.
7.A history of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
8.Participation in other clinical trials with a new chemical entity within the previous 3 months.
9.Significant illness other than diabetes within 2 weeks prior to first dosing.
10.Known human deficiency virus (HIV) or hepatitis.
11.Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigators makes the patient non-eligible for the study.
12. Diabetes-protective HLA-DQ6-genotype.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1 diabetes from 4 years of age. The subjects will be followed for 5 years. <br><br> <br>;Secondary Objective: The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta-cell autoimmunity as indicated by multiple positive islet cell autoantibodies. <br>;Primary end point(s): The primary objective is to show that the treatment is safe in children at risk for type 1 diabetes. <br>The primary endpoint of effect is the proportion of subjects in the two treatment groups who develop type 1 diabetes, according to the American Diabetes Association criteria, during the study period.<br>;Timepoint(s) of evaluation of this end point: At 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): As secondary variables of effect we will use 1) change in first-phase insulin response on IvGTT from baseline, 2) fasting and 2 hours C-peptide levels on OGTT as well as AUC, 3) the 120 min glucose value and AUC glucose from OGTT and 4) change in HbA1c from baseline.;Timepoint(s) of evaluation of this end point: At 5 years