CMV is a highly contagious viral infection that can harm an unborn child.
What is the purpose of this CMV clinical research study?
When a person becomes pregnant, the virus goes dormant, and the newborn has an increased risk of birth defects. Congenital CMV occurs when a newborn is born with cytomegalovirus (CMV) infection. Congenital CMV affects about one out of every 200 infants. Congenital CMV infection affects about one out of every five babies, resulting in long-term health issues.
Vaccines aim to safely protect people against infections, and clinical research studies are vital to creating vaccines. A clinical trial can help researchers understand whether an investigational vaccine is safe and effective. The purpose of this clinical trial is to
- Evaluate the safety and effectiveness of an investigational vaccine (a vaccine not yet approved by a country’s drug regulatory agency) called mRNA-1647 against cytomegalovirus (CMV) infection in women who have not had prior CMV infection
- Evaluate its safety in women who test positive for CMV due to prior exposure.
- 1 About cytomegalovirus and congenital CMV infection. cdc.gov. Updated August 18, 2020. Accessed December 7, 2020.
- 2 Manicklal S, Emery VC, Lazzarotto T, et al. The “silent” global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013;26(1):86-102.mRNA-1647-P301_Brochure_US_English_V3_dated23August2021
- About CMV
CMV is a leading cause of birth defects around the world and is the number one infection that causes birth defects in the U.S.1,2 CMV is a common viral infection that usually goes unnoticed or only causes mild symptoms in most people. But if a woman becomes infected with CMV while she is pregnant, she can pass the infection to her unborn baby. This can cause her child to suffer long-term disability due to birth defects, including hearing loss, or even death in very severe cases.
Currently, there is no approved vaccine against this devastating virus. That is why it is so important that we work together to make sure investigational vaccines are safe and effective to protect the most vulnerable against infection
Study Eligibility Criteria
Women Ages 18 – 40
Not pregnant or planning on becoming pregnant within the next 9 months
In good health
In close contact with at least one child 5 years of age or younger