Investigational vaccine targeting CMV, the #1 infectious cause of birth defects in the U.S.


Posted: June 03, 2022 | Word Count: 551

Whether you're planning to become a first-time mom, or you've been around the baby block before and are ready to expand your family again, everyone has the same priority: to have a healthy child. That's why it's important to learn that one of the most common causes of birth defects in the U.S. is connected to a virus called cytomegalovirus, and it occurs in one of every 200 births.1

Cytomegalovirus basics

Cytomegalovirus, shortened to CMV, is the most common vertically transmitted infection and a leading cause of birth defects around the world. It is the #1 non-genetic cause of sensorineural hearing loss in babies. CMV is a common viral infection that usually goes unnoticed or only causes mild symptoms in most people. In fact, over half of adults have been infected with CMV before age 40 and don't even know it.1

"The problem is if a woman becomes infected with CMV while she is pregnant, she can pass the infection to her unborn baby," said Dr. Lori Panther, MD, MPH. “This can cause her child to suffer long-term disability due to birth defects, including hearing loss, or even death in very severe cases."

CMV is commonly spread through close contact with an infected person and can be transferred in bodily fluids, such as saliva or urine, of an infected person. Currently, there is no approved vaccine for the prevention of CMV infection.

Clinical trials

About one in five babies born with a CMV infection will have birth defects or other long-term health problems, such as hearing loss or developmental delays. Moderna is currently evaluating an investigational vaccine to understand whether it can help the immune system to protect against CMV, therefore helping women before they become pregnant.

Vaccines aim to safely protect people against infections, and clinical trials are vital to creating vaccines. A clinical trial can help researchers understand whether an investigational vaccine is safe and effective. By participating in the CMVictory Trial, you can help create a future where we may hopefully declare victory and prevent the spread of CMV.

This clinical trial is sponsored by Moderna who is studying mRNA-1647, an investigational vaccine, in women between 16-40 years of age. The purpose of this clinical trial is to:

  • Evaluate the investigational vaccine (a vaccine not yet approved by a country’s drug regulatory agency), mRNA-1647, against CMV.
  • Evaluate the safety of the investigational vaccine in women who test positive to prior exposure to CMV.

To learn more about the Moderna Therapeutics Phase 3 clinical trial, CMVictory, evaluating mRNA-1647, visit CMVictory.com.

Who can join?

This clinical trial is looking for volunteers. To join this clinical trial, you must be:

  • A woman between 16-40 years of age
  • In good health
  • In close contact with at least one child 5 years of age or younger for at least 8 hours a week, if age 20 or older
  • Not pregnant or planning on becoming pregnant within the next 10 months

Clinical trial staff will explain any additional requirements and answer any questions you or a loved one may have about participation. You may stop participation in the clinical trial at any time without providing a reason.

Reference:

1. Centers for Disease Control and Prevention (CDC). Cytomegalovirus (CMV) and congenital CMV infection. August 2020. Retrieved March 23, 2022, from https://www.cdc.gov/cmv/index.html.

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