RSV OA=ADJ-013

The Clinical Trial Site of ITM is seeking volunteers for a new clinical trial entitled RSV OA=ADJ-013. In this study, we will evaluate how the human body responds to the simultaneous administration of a novel RSV and a marketed COVID-19 vaccine.

• For whom: healthy volunteers of at least 50 years old, who received at least one COVID-19 vaccine in the past

• Start: June / July 2024

• Duration: 6-7 months

• Study visits: 2 or 3 visits to the study centre, and 1 follow-up phone call

• Compensation: Fixed compensation per study visit, for your time and travel expenses

Purpose of the study

The respiratory syncytial virus (RSV) is a seasonal virus that can cause severe lower respiratory tract infections in older adults and adults with chronic medical conditions. A significant number of older adults with influenza-like symptoms have a confirmed RSV infection, and many of them even require hospital admission.

Although COVID-19 seasonality is yet to be determined, the analysis of severe COVID-19 outcomes since the start of the pandemic revealed that the disease has had a more significant impact during the time frame that aligns with the conventional influenza and RSV seasons, meaning that both the RSV and the COVID-19 vaccines are indicated for the same individuals at the same time. Therefore, evaluation of the simultaneous administration of both vaccines is of great interest.

Conduct of the study

In order to evaluate the effect of simultaneous administration, all participants will be divided in one of two groups: the first group will receive both vaccines at the same time, while the second group will receive them with an interval of about 30 days. The allocation to one of these groups is done completely random by a computerised system.

When you are invited to participate, you will be screened during the first visit. There are many factors that contribute to this decision, which the study doctor will review together with you. If you qualify, we will take a small blood sample from you, and administer the first vaccine. Depending on the group you are assigned to, you will also get your second vaccine, or you will have to return 30 days later to receive it.

More or less 30 days after your last dose, we ask you to return one more time to review potential side effects and take a final blood sample.

Finally, about 6 months after your last vaccine, we will contact you once more by phone to follow up on the effects of the vaccination.

Who can participate?

You MAY join this study if you:

• are at least 50 years old,

• are in good health,

• have had at least one COVID-19 vaccine in the past.

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 compensation per study visit.

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

Team

• Principal investigator: Prof Dr Laurens Liesenborghs (MD, PhD)