Using influenza vaccination to help manage type 1 diabetes
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
This study is testing if getting the flu vaccine can help people with early type 1 diabetes keep their insulin-producing cells working better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 10 sites (Aalborg and 9 other locations) |
| Trial ID | NCT05585983 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of influenza vaccination on preserving β cell function in patients with early type 1 diabetes mellitus. It is a multicenter, prospective, randomized, controlled trial comparing the outcomes of patients receiving the influenza vaccine against those receiving a placebo. The study aims to determine if vaccination can sustain β cell function and improve disease management by measuring various health markers and immune responses. The trial is designed to provide insights into a potential immunotherapy approach for delaying the progression of type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults aged 7 to 17 who have recently been diagnosed with type 1 diabetes and are hospitalized.
Not a fit: Patients who have received an influenza vaccination during the current season or have severe allergies to vaccine components may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a simple and cost-effective method to preserve insulin-producing cells in patients with early type 1 diabetes.
How similar studies have performed: While the concept of using vaccination to modulate autoimmune responses is promising, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalborg and 9 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Copenhagen, Denmark (Recruiting)
- Gødstrup Hospital — Herning, Denmark (Recruiting)
- Holbaek Sygehus — Holbæk, Denmark (Recruiting)
- Nykoebing F Sygehus — Nykøbing Falster, Denmark (Recruiting)
- Randers Regional Hospital — Randers, Denmark (Recruiting)
- Sjællands Universitetssygehus — Roskilde, Denmark (Recruiting)
- Slagelse Hospital — Slagelse, Denmark (Recruiting)
- Viborg Regional Hospital — Viborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Ole Frøbert, MD, PhD
- Email: olefro@clin.au.dk
- Phone: 0046730895413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.