Are you interested in receiving an experimental vaccine against Cytomegalovirus (CMV), or having your child vaccinated against 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 or your child may qualify to participate in this study if:
- You/they are male ages 9 to 15 years inclusive, or female ages 16 to 25 years inclusive
- If 9 to 15 years of age: Has a body mass index (BMI) at or above the third percentile according to World Health Organization Child Growth Standards
- If 16 to 25 years of age: Has a BMI of 15-35 kg/m2
- According to the investigator, the participant is in good general health and is capable of complying with study procedures
- If 9 to 15 years of age: Is able to provide written informed consent/assent, as applicable to the participant or the parent/legally authorized representative (LAR)
- If 16 to 25 years of age: Is able to provide written informed consent
- According to the assessment of the Investigator, understands and is willing and physically able to comply with protocol-mandated follow-up, including all study visits and procedures anticipated during the 18-month study period, as applicable to the participant, or parent(s)/LAR(s)
- If a female participant is of childbearing potential, the participant fulfills all the following criteria:
- Has a negative urine pregnancy test at Screening and a negative urine pregnancy test on the day of the first injection
- Has practiced a highly effective or an acceptable method of contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection
- Has agreed to continue a highly effective or an acceptable method of contraception or abstinence through 3 months following the participant’s final study injection
- If applicable, sexually active male participants of reproductive potential must agree to consistently use a highly effective or an acceptable method of contraception from the time of the first study injection 3 months after the participant’s final study injection
You or your child may not qualify to participate in this study if:
- You/they 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. This includes but is not limited to the following:
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease
- Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas)
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1647 vaccine or any components of the mRNA-1647 vaccine
- Reported history of bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy
- Any medical, psychiatric, or other condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results
- You/they has received, or plans to receive, any nonstudy vaccine <28days prior to or after any study injection; in addition, the following criteria for coronavirus disease 2019 (COVID-19) and influenza vaccines apply:\
- Any COVID-19 vaccination primary series must have been completed ≥ 28 days prior to receiving any dose of the study injection
- COVID-19 vaccines (including any booster doses; regardless of manufacturer) must be administered ≥ 28 days prior to or after any study injection
- Influenza vaccines may be administered > 14 days prior to or after any study injection
- You/they have received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of enrollment
- You/they 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 plans to do so during the course 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.