By Ethan Covey

A vaccine for cytomegalovirus (CMV), a common virus linked to high rates of birth defects, is entering phase 3 clinical trials.

Moderna is evaluating the safety and efficacy of a messenger RNA CMV vaccine (mRNA-1647) against primary CMV infection in women who are between 16 and 40 years of age in a study known as CMVictory.

According to the National CMV Foundation, CMV is the most common viral infection and leading cause nongenetic cause of hearing loss in infants who are born in the United States. However, 91% of women are unaware of CMV.

The combination of widespread infection and limited awareness “makes the burden of disease uniquely significant,” Allison August, MD, the vice president of clinical development and infectious diseases at Moderna, in Cambridge, Mass., told Infectious Disease Special Edition.

Once infected with CMV, the virus stays in a person’s body for life. While CMV typically presents in adults with symptoms similar to a common cold, it can have serious outcomes in people with weakened immune systems and newborns.

One in three expecting mothers infected with CMV will pass the virus to their unborn children, and the risk increases when there are other children or toddlers in a household. Approximately one in 200 children each year are born with congenital CMV, and roughly one in five of these will develop birth defects or other serious health problems.

“The risk really centers on the prevalence and the lack of awareness among women, particularly when it comes to the risk factors,” Dr. August said. “In adults, initial infection with CMV often goes undetected and is very common. Over half of adults are infected by age 40, and the risk is two times higher in Black communities. As there is currently no approved vaccine for CMV, it’s important that more people are educated about CMV, and the proactive and effective ways to help reduce the risk of CMV transmission.”

The risk for CMV transmission can be decreased by measures such as handwashing, not sharing utensils or toothbrushes, and avoiding saliva contact with children. An effective vaccine would greatly decrease the risk for negative outcomes.

Dr. August reported no relevant financial disclosures other than her employment.