Are you interested in receiving an experimental vaccine against Cytomegalovirus (CMV)?
This clinical research study is looking at the safety and effectiveness of a vaccine for Cytomegalovirus, a virus that most people aren’t aware they have as it rarely causes problems in healthy people. This virus is of most concern to pregnant women and those with weakened immune systems. For people who have weakened immune systems, especially people who have had an organ, stem cell or bone marrow transplant, CMV infection can be fatal.
There is currently no approved vaccine for the prevention of Cytomegalovirus infection.
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 at risk of contracting Cytomegalovirus, 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 female between the ages of 16 and 40 at the time of giving informed consent
- According to the assessment of the Investigator, are in good general health and are capable of complying with study procedures
- For female participants aged 20 years or older, have or anticipate having direct exposure (in the home, socially, or occupationally) to at least 1 child 5 years of age or younger. Direct exposure is defined as either a) participant is the parent, or b) participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week
- Have a body mass index of 15-35 kg/m^2
You may not qualify to participate in this study if you:
- Are of non-childbearing potential
- Have a history of a diagnosis or condition that, in the judgement of the Investigator, is clinically unstable or may affect participant safety
- Receive or plan to receive any nonstudy vaccine less than 28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
- Any Coronavirus disease 2019 vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection
- COVID-19 vaccines must be administered at least 28 days prior to or after any study injection
- Influenza vaccines may be administered > 14 days prior to or after any study injection
- Have received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of first injection, or plan to do so during the course of the study
- Have previously received and investigational CMV vaccine
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.