Study background

Cytomegalovirus (CMV) is the most common infectious cause of birth defects and causes more childhood deaths than Down Syndrome. CMV infection usually does not cause symptoms, however, if the mother is exposed during pregnancy, it can cause problems for the unborn child. Up to 12% of children will die in their first year of life with 80% going on to survive with lifelong disabilities such as hearing loss. CMV is a very common virus with most adults expected to be infected at some point in their lifetime.

This research study is being conducted as there is currently no available vaccine for CMV. If you agree to take part, you will be assigned randomly to receive either the investigational study vaccine or a placebo.

Study Details

The study would require you to come to the clinic approximately 8 times over the first year and then a visit every 3 months for the next 18 months. Visits will range between 15 mins to an hour each time you come in. Over the course of the study, we will check your medical history, draw blood, and inject the investigational study vaccine or placebo. The investigational study vaccine or placebo will be administered 3 times over the duration of the study. You will also need to complete a safety form in an app on your phone for 7 days following each administration of the investigational vaccine.

You will be reimbursed for your time in the research study.

Eligibility criteria

  • Aged over 16 to 40 years
  • Is a woman
  • If a woman is over 20 years of age they must have direct exposure to children 5 years or younger each week
  • No history of autoimmune conditions

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