Questions?

Cytomegalovirus (CMV) is a common viral infection that usually goes unnoticed. For most people, the symptoms of CMV—if any—may resemble the common cold, such as fatigue, fever, and sore throat. CMV is found in bodily fluids like saliva, so it is easily passed from person to person in everyday situations. Once someone is infected with CMV, it stays inactive, or “sleeps,” in the body for life.¹ At certain times in a person’s life, such as during 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 Infection-related long-term disability include hearing loss, vision loss, and cerebral palsy.² 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.

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

CMV is very common and affects people of all ages. The older kids and adults get, the more likely it is they have been exposed to CMV.¹

CMV has an unevenly high presence in communities of lower socioeconomic status and minority populations, including African American and Latino.³

Normally, vaccines for viruses are made from a weakened or inactive (not live) version of the virus, but messenger RNA (mRNA) is different. It is made from an instructional molecule called mRNA that naturally occurs in the body and teaches the body how to make proteins. Participants cannot become infected with CMV from getting the trial vaccine.

Given that different ages, sexes, races, and ethnicities can respond differently to medical therapies, it is important that this clinical trial include diverse people. A diverse group of participants helps researchers understand how different people react to the investigational vaccine and make sure that it is safe and effective for everyone.

Moderna is committed to researching safe and effective mRNA-based vaccines and therapies to bring better health and living to people of all ages, sexes, and backgrounds.

Compensation for participants’ trial-related time may be provided. The clinical trial site can provide more details.

Clinical trials are completely voluntary. Participants may leave the clinical trial at any time, without giving a reason for doing so.

Clinical trials follow a specific set of standards and are closely regulated to help protect participants. Any known risks or side effects will be discussed during the informed consent process, and clinical trial staff will monitor participants for side effects throughout the trial. Participants should contact the clinical trial staff if they are having side effects or experiencing a change in their medical condition.

All clinical trials and investigational treatments have risks, including the potential to make participants sick or uncomfortable. Although safety precautions are in place, their condition could remain the same, improve, or get worse. If a participant chooses to take part in this trial, they are at risk for side effects. Side effects may include, but are not limited to, headache, fatigue, muscle pain, and chills. Discuss these with the clinical trial staff and, if desired, a regular doctor.

Taking part in this clinical trial is completely optional. Taking part in a clinical trial may have an impact on your daily schedule. When deciding whether to volunteer, please consider the time needed for visits (possibly including travel away from home) and any responsibilities that may interfere with the clinical trial.

There are still other ways to contribute to preventing the spread of CMV, such as helping to raise awareness in your community and online. We also hope that you continue exploring treatment and clinical trial options with your doctor.