INfluenza VaccInation To Mitigate typE 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaxigrip Tetra Sanofi Pasteur Europe.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
Overview
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.
Interventions
- Biological Vaxigrip Tetra Sanofi Pasteur Europe
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.
Primary outcome measures
- Change in fasting residual β cell (C-peptide) function. [Time frame: 12 months]
Secondary outcome measures (5)
- Change in fasting residual β cell (C-peptide) function. [Time frame: 6 months.]
- Change in HbA1c [Time frame: 12 months.]
- Change in insulin requirements. [Time frame: 12 months.]
- Time-In-Range of blood glucose. [Time frame: 12 months.]
- Variation of blood glucose. [Time frame: 12 months.]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 10 centers
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital — Aarhus
- Steno Diabetes Center Copenhagen — Copenhagen
- Gødstrup Hospital — Herning
- Holbaek Sygehus — Holbæk
- Nykoebing F Sygehus — Nykøbing Falster
- Randers Regional Hospital — Randers
- Sjællands Universitetssygehus — Roskilde
- … and 2 more centers
Publications
- Pedersen IB, Kjolby M, Hjelholt AJ, Madsen M, Christensen AR, Adolfsen D, Hjelle JS, Kremke B, Stovring H, Jessen N, Vestergaard ET, Kristensen K, Frobert O. INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes. BMJ Open. 2024 Jul 1;14(6):e084808. PMID 38950997
Identifiers
NCT: NCT05585983 · INVITED-2022