About the CMVibe Trial Trial

This clinical trial is sponsored by Moderna. The purpose of the CMVibe Trial is to evaluate the safety and immune response of mRNA-1647, which aims to prevent CMV infection in children 9 to 15 years of age. mRNA-1647 has already been looked at for safety in people 9 years of age and older.

What Is CMV?

CMV is a common and often overlooked virus with a potential lifelong impact. For most people, the symptoms of CMV—if any—may resemble the common cold with fatigue, headache, and sore throat. Unfortunately, once CMV is in the body it’s there for life, “sleeping” in the body.1 At certain times in a person’s life, such as pregnancy, CMV can reactivate.

An active CMV infection during pregnancy puts the unborn baby at risk of birth defects. These include hearing loss, vision loss, or cerebral palsy, which can lead to long-term disability or, in severe cases, death.2

Currently, there is no approved vaccine for the prevention of CMV infection.

Hearing Loss

Vision Loss

Cerebral Palsy

Cerebral palsy, caused by abnormal brain development, makes muscle control difficult. Children with cerebral palsy may need special equipment to walk or may not be able to walk at all. They may also have joint problems, speech problems, or seizures.

If we advance research of a potential vaccine for kids and teens against CMV, we could potentially help protect them against getting this infection before it has the chance to impact their futures—and their future children.

What to Expect in the CMVibe Trial

The total length of participation in this clinical trial is approximately 1½ years (18 months).

  • Potential participants will have a screening visit to check whether they are eligible to join. The visit includes a wellness exam, review of medical history, and some blood tests.
  • It includes 12 scheduled in-person visits and 11 phone calls to check in with participants, or their parent(s) or caregiver(s), about any updates in health.
  • Participants will get a total of 3 injections of the trial vaccine. An injection will be given in the upper arm at 3 different visits during the first 6 months of the clinical trial.
  • Participants, or their parent(s) or caregiver(s), will enter information about how they are feeling into a device called an eDiary on the day they get each injection and for 6 days after each injection.

To understand whether the trial vaccine is safe and works, it will be compared with a placebo (which contains no active ingredients). Participants will be assigned to receive mRNA-1647 or the placebo by chance. All clinical trial participants will get the same level of care regardless of which injection they receive.

Take the prescreener

Clinical Trial Participants Are Essential

Vaccines aim to protect people against viral infections, and clinical trials are an important step in creating vaccines.

Without clinical trial participants, researching potential new vaccines would not be possible.