FLU SV MRNA-002

The Clinical Trial Site of ITM is seeking volunteers for a new clinical trial entitled FLU mRNA-002. In this study, we are evaluating a new flu vaccine designed to work against multiple flu viruses. We will look at whether the new vaccine is safe and how the human body responds to it.

• For whom: Healthy volunteers between the ages of 18 and 85 with no flu vaccination in the past 6 months

• Start: November 2023

• Duration: 6-7 months

• Study visits: 6 study centre visits and 2 follow-up phone calls

• Compensation: Fixed compensation for your time and travel expenses

Purpose of the study

Influenza viruses are known to cause high seasonal disease and are a major cause of increased morbidity and mortality in humans. Annual influenza vaccination is the best strategy to prevent influenza and its complications. Influenza viruses are constantly changing, allowing them to bypass pre-existing immunity. Therefore, flu vaccines must be reconstituted and administered every year.

The new vaccine under investigation is expected to work against multiple influenza viruses and is mRNA-based. An advantage of mRNA vaccines is that they can be developed and produced more quickly. Since influenza viruses change frequently, being able to produce vaccines faster could help target specific influenza viruses and better protect people against them.

Conduct of the study

We are looking for healthy participants between the ages of 18 and 85 who have not had a positive flu test and flu vaccination in the past 6 months.

If you are invited to participate in the study, you must undergo a screening at your first visit, during which the study will be explained to you in detail and study staff will determine if you meet all eligibility criteria. If you are eligible, a blood sample will be drawn and you will receive your study vaccination according to the study group in which you are randomly assigned. This means you will receive either one of the mRNA seasonal flu vaccines being studied or another vaccine approved by health authorities for the 2023-2024 flu season (as a comparator). However, neither you nor the research team will know which group you are assigned to until after the end of the study.

Subsequent study visits (both on-site and by telephone) will focus on monitoring the effectiveness and possible side effects of the vaccine. A new blood sample will be taken each time during the study centre visits.

The entire study will take about 6-7 months, with 6 visits to our study centre and 2 follow-up phone calls.

Compensation

To compensate you for your time, any expenses you incur to participate in the study, and any other inconveniences you may experience, you will receive a fixed fee per study visit.

If you commit to participating in the study, we strongly urge you to complete the entire study. However, please know that you can withdraw your participation at any time.

Questions?

Contact us at studies@itg.be.