INfluenza VaccInation To Mitigate typE 1 Diabetes

INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)

Sponsors

Lead Sponsor: Aarhus University Hospital

Source Aarhus University Hospital
Brief Summary

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.

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.

Overall Status Not yet recruiting
Start Date 2022-10-24
Completion Date 2026-06-01
Primary Completion Date 2025-04-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in fasting residual β cell (C-peptide) function. 12 months
Secondary Outcome
Measure Time Frame
Change in fasting residual β cell (C-peptide) function. 6 months.
Change in HbA1c 12 months.
Change in insulin requirements. 12 months.
Time-In-Range of blood glucose. 12 months.
Variation of blood glucose. 12 months.
Enrollment 100
Condition
Intervention

Intervention Type: Biological

Intervention Name: Vaxigrip Tetra Sanofi Pasteur Europe

Description: 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.

Eligibility

Criteria:

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 (September 1 - March 1). - 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.

Gender:

All

Minimum Age:

7 Years

Maximum Age:

17 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2022-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aarhus University Hospital

Investigator Full Name: Ole Frøbert, MD, PhD

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Influenza vaccination

Type: Experimental

Description: Influenza vaccine, 0.5 mL.

Label: Placebo

Type: Placebo Comparator

Description: Placebo, 0.5 mL saline.

Acronym INVITED
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: In this double blind, placebo-controlled clinical trial participants are allocated to either influanza vaccination (active) or to placebo (control).

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: 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.

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