- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05585983
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED)
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ole Frøbert, MD, PhD
- Phone Number: 0046730895413
- Email: olefro@clin.au.dk
Study Locations
-
Denmark
-
-
Aarhus, Denmark
- Recruiting
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent (parents, legal guardian).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Influenza vaccination
Influenza vaccine, 0.5 mL.
|
We will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 μg of hemagglutinin per strain consistent with WHO recommendations according to season.
|
Placebo Comparator: Placebo
Placebo, 0.5 mL saline.
|
We will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 μg of hemagglutinin per strain consistent with WHO recommendations according to season.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting residual β cell (C-peptide) function.
Time Frame: 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)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting residual β cell (C-peptide) function.
Time Frame: 6 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, 6 months/ AUC 0-4 h, C-peptide, baseline)
|
6 months.
|
Change in HbA1c
Time Frame: 12 months.
|
Measured as standard laboratory test in mmol/mol
|
12 months.
|
Change in insulin requirements.
Time Frame: 12 months.
|
Measured as total insulin dose per kg body weight per day as a mean for the last 14 days.
|
12 months.
|
Time-In-Range of blood glucose.
Time Frame: 12 months.
|
Defined as percentage time in range (3.9-10.0
mmol/L) of continuous glucose monitoring over 14 days.
|
12 months.
|
Variation of blood glucose.
Time Frame: 12 months.
|
Determined as percent coefficient of variation of blood glucose over 14 days.
|
12 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with stimulated C-peptide >0.2 pmol/mL
Time Frame: 12 months
|
Proportion of participants in each of the treatment groups with stimulated C-peptide >0.2 pmol/mL
|
12 months
|
HbA1c time in range
Time Frame: 12 months.
|
Defined as percentage time in range (48mmol/mol or below)
|
12 months.
|
Insulin Dose Adjusted A1c
Time Frame: 12 months
|
Defined as: IDAA1c = HbA1c (%) +4*total daily insulin dose (IE/kg/24 h)
|
12 months
|
Variation of blood glucose.
Time Frame: 6 months.
|
Determined as percent coefficient of variation of blood glucose over 14 days.
|
6 months.
|
Change in GAD 65 antibodies.
Time Frame: 12 months.
|
Laboratory method to be determined
|
12 months.
|
Change in GAD 65 antibodies.
Time Frame: 6 months.
|
Laboratory method to be determined.
|
6 months.
|
Change in regulatory T cells.
Time Frame: 12 months.
|
Defined as percentage change.
|
12 months.
|
Change in insulin autoantibodies.
Time Frame: 12 months.
|
Laboratory method to be determined.
|
12 months.
|
Change in zinc transporter-8 autoantibodies
Time Frame: 12 months.
|
Laboratory method to be determined.
|
12 months.
|
Change in islet cell autoantibodies.
Time Frame: 12 months.
|
Laboratory method to be determined.
|
12 months.
|
Change in cytokine levels.
Time Frame: 12 months.
|
Markers to be determined: IL2, IL6, IL8, IL10, TNFα.
Laboratory method to be determined.
|
12 months.
|
Change in cytokine levels.
Time Frame: 6 months.
|
Markers to be determined: IL2, IL6, IL8, IL10, TNFα.
Laboratory method to be determined.
|
6 months.
|
Unplanned hospitalizations.
Time Frame: 12 months.
|
Number of unplanned hospitalizations with reasons for hospitalizations.
|
12 months.
|
Serum hemagglutinin inhibition antibody titers against the four viruses included in the vaccine
Time Frame: 12 months.
|
Antibody titers.
|
12 months.
|
Serum hemagglutinin inhibition antibody titers against the four viruses included in the vaccine
Time Frame: 6 months.
|
Antibody titers.
|
6 months.
|
Clnical endpoints.
Time Frame: Up to 5 years.
|
Hospitalizations and unplanned hospital contacts.
|
Up to 5 years.
|
Treatment-emergent hypoglycemic events (safety outcome)
Time Frame: Up to 12 months.
|
Hypoglycemic events reported according to the American Diabetes Association classification
|
Up to 12 months.
|
Treatment-emergent events of diabetic ketoacidosis (safety outcome)
Time Frame: Up to 12 months.
|
Events of diabetic ketoacidosis.
|
Up to 12 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INVITED-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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