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Study on the Effect of Influenza Vaccine on Preserving Beta Cell Function in Early Type 1 Diabetes Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The INVITED trial is a clinical study focused on Type 1 diabetes, a condition where the body's immune system attacks the cells in the pancreas that produce insulin. This study is investigating whether the Vaxigrip Tetra vaccine, which is a type of flu shot, can help preserve the function of these insulin-producing cells in people who have recently been diagnosed with Type 1 diabetes. The vaccine is given as an injection into the muscle.

The purpose of the study is to see if getting the flu vaccine can help maintain the body's ability to produce insulin in people with early Type 1 diabetes. Participants in the study will receive either the flu vaccine or a placebo. The study will track changes in the body's ability to produce insulin over a period of 12 months. This will be measured by looking at levels of a substance called C-peptide, which indicates how well the pancreas is working. Other factors, such as blood sugar levels and insulin needs, will also be monitored.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the vaccine. The study aims to provide valuable information on whether the flu vaccine can be a helpful treatment in managing early Type 1 diabetes by preserving the function of insulin-producing cells.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the INVITED trial, you will be required to provide written informed consent. This consent must be given by your parents or legal guardian if you are under 18 years of age.

    You must be between 7 and 18 years old and have been recently diagnosed with type 1 diabetes to participate in this trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish baseline measurements. This includes measuring your fasting C-peptide levels, which help assess your body's ability to produce insulin.

    Your HbA1c levels, which indicate your average blood sugar levels over the past three months, will also be recorded.

  3. Step 3

    Vaccination

    You will receive the Vaxigrip Tetra vaccine, which is an influenza vaccine given as an intramuscular injection. This vaccine is intended to help determine if it can preserve your body's ability to produce insulin.

    The vaccine is administered as a single dose using a pre-filled syringe.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will occur at various intervals to monitor changes in your fasting C-peptide levels and HbA1c levels over time.

    These assessments will take place at 6 months and 12 months after the initial vaccination.

  5. Step 5

    Continuous glucose monitoring

    At 12 months, your glucose levels will be continuously monitored over a 14-day period. This will help assess the time your glucose levels remain within the target range of 3.9-10.0 mmol/L.

    The variation in your glucose levels will also be measured to understand how stable your blood sugar levels are over this period.

  6. Step 6

    Final evaluation

    A final evaluation will be conducted to assess any changes in your insulin requirements. This will be measured as the total insulin dose per kilogram of body weight per day, averaged over the last 14 days.

    The trial aims to determine if the influenza vaccination has helped preserve your body's ability to produce insulin over the course of 12 months.

Who can join the trial?

4 criteria

  • Patients who have been hospitalized with newly diagnosed type 1 diabetes.
  • Both male and female participants are eligible.
  • Participants must be 7 years old or older but younger than 18 years.
  • Written informed consent is required from parents or a legal guardian. This means that the parents or legal guardian must agree in writing for the child to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who do not have Type 1 diabetes cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not willing to receive an influenza vaccination cannot participate.
  • Patients with any other medical condition that might interfere with the study cannot participate.
  • Patients who are pregnant or planning to become pregnant during the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of severe allergic reactions to vaccines cannot participate.
  • Patients who have received an influenza vaccine within the last 6 months cannot participate.
  • Patients who have a compromised immune system cannot participate.
  • Patients who are unable to comply with the study procedures cannot participate.
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Investigated drugs

Influenza Vaccine is a type of vaccine designed to protect against the influenza virus, commonly known as the flu. In this clinical trial, the vaccine is being used to see if it can help preserve the function of certain cells in the pancreas, called beta cells, in people who are in the early stages of type 1 diabetes. These beta cells are important because they produce insulin, which helps control blood sugar levels. The goal is to find out if getting the flu vaccine can help keep these cells working better for longer in people with type 1 diabetes.

What is already known about the treatment

Influenza Vaccine – The influenza vaccine is administered through an injection, typically into the muscle of the upper arm. It is currently well-established in medical practice and literature as a preventive measure against the flu. In the context of the INVITED trial, it is being investigated for its potential to preserve beta cell function in individuals with early type 1 diabetes. The vaccine works by stimulating the immune system to recognize and fight the influenza virus, potentially reducing inflammation that could harm beta cells. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. The disease typically begins in childhood or young adulthood, but it can develop at any age. It progresses as the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the disease advances, it requires careful management of blood sugar levels through lifestyle adjustments and monitoring.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2022-500906-17-01Protocol codeINVITED-2022Estimated enrolment100 patientsSponsorRegion Midtjylland

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