Respiratory Syncytial Virus (RSV) Investigational Vaccine Research Study

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:

• Can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).

FOR STUDY GROUP 1

• Are 18-49 years of age at the time of the study intervention administration.
• Have been diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:
  • Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long‑term medication:
    • Chronic obstructive pulmonary disease (COPD)
    • Asthma
    • Cystic fibrosis
    • Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis
    • Chronic heart failure
    • Cardiac arrhythmia
  • Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
  • Other diseases at increased risk for RSV disease
    • Chronic kidney disease
    • Chronic moderate to severe liver disease
    • Neurologic or neuromuscular conditions

FOR STUDY GROUP 2

• Are greater than or equal to 60 YOA at the time of the study intervention administration.
• Have any chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator.
• Are living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

You may not qualify to participate in this study if you:

• Have any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
• Have any unstable chronic illness.
• Have any history of dementia or any medical condition that moderately or severely impairs cognition.
• Have recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
• Have any significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
• Have used any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention.
• Have had any previous vaccination with any RSV vaccine, including investigational RSV vaccines.
• Are bedridden
• Are pregnant or plan to become pregnant during the duration of the study.

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.