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 willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by yourself and by study staff when indicated
- Are a healthy participant who is determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study
- Are an adult who is ambulatory and lives in the community, or in assisted living or long-term care residential facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living
- Are male or female 60 years of age or older, inclusive
You may not qualify to participate in this study if you:
- Have bleeding diathesis or a condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- Have a history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine
- Have any serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator’s opinion, excludes you from participating in the study
- Are an immunocompromised individual with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
- Have any other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study
- Receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted
- Have a previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation
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.