Are you interested in receiving an experimental vaccine against RSV?
This clinical research study is looking at the safety and effectiveness of a vaccine for Respiratory Syncytial Virus (RSV), a contagious virus that can cause infections in the lungs and air passages. People of all ages can be infected with RSV, and infections may occur more than once, even within the same year. Older adults, especially those older than 60, are at rick of developing a serious infection caused by RSV. There is currently no approved vaccine for the prevention of RSV infection, nor specific therapeutics beyond supportive care to treat an infection with RSV.
Would you like to take part?
As a volunteer in a research study, you will receive study-related medical care from the study doctor and regular follow up of your condition to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to other patients with RSV, and whether it will be made widely available in Canada. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are ≥ 60 years of age and are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria:
- absence of changes in medical therapy within 1 month due to treatment failure or toxicity
- absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1
- and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely
- Have a body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2
You may not qualify to participate in this study if you:
- Have participated in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination
- Have participated in research involving receipt of any investigational RSV product (drug/biologic/device)
- Have a history of serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization
- Have received or plan to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are:
- seasonal influenza vaccines
- pneumococcal vaccines
- authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.