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 a female or male 9 to 15 years of age, or are a female 16 to 25 years of age at the time of consent.
- Are in good general health, in the opinion of the Investigator, and is capable of complying with study procedures.
- For the CMV-seronegative cohorts: At the Screening visit, are CMV IgG-negative and CMV immunoglobulin M (IgM)-negative.
- For CMV-seropositive cohorts: At the Screening visit, are CMV IgG-positive and CMV IgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMV IgM-indeterminate. Participants with an isolated positive or indeterminate result for CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMV IgM-indeterminate) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening.
- At 9 to 15 years of age, have a body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards. If 16 to 25 years of age: have a BMI of 15 to 35 kilograms (kg)/square meter (m^2)
- Female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration.
You may not qualify to participate in this study if you:
- Have a history of a diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- Have received, or plan to receive, any nonstudy vaccine <28 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 enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥10 mg/day prednisone equivalent).
- Have received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of the first study injection (Day 1) or plan to do so during the course of the study.
- Report a history of myocarditis, pericarditis, or myopericarditis.
- Have reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.
- Have previously received an 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.