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Moderna Doses the First Participant in Study of CMV mRNA Vaccine
The Phase 3 study of Moderna’s mRNA vaccine will evaluate the safety and efficacy of the vaccine against primary CMV infection in women ages 16 to 40 years from 150 sites globally.
Moderna recently dosed the first participant in the Phase 3 pivotal registration study of its cytomegalovirus (CMV) mRNA vaccine candidate, mRNA-1647.
The CMVictory study will evaluate the safety and efficacy of mRNA-1657 against primary CMV infection in nearly 8,000 women ages 16 to 40 years from 150 sites globally, beginning in the US. Notably, about 42 percent of participants will be persons of color, helping to deliver on industry calls for more diversity in clinical trials.
Previously, Phase 1 and 2 studies showed functional antigen-specific responses that support the vaccine candidate’s potential to prevent CMV infection.
For example, data from the seven-month Phase 2 study demonstrated that 50 micrograms, 100 micrograms, and 150 micrograms of mRNA-1647 were generally well-tolerated. Based on these results, researchers chose the 100 microgram dose for the Phase 3 study.
“The start of the second Phase 3 study in our company’s history is an exciting milestone for Moderna and I would like to thank the Moderna team as well as our partners at clinical trial sites. This study will allow us to get closer to our goal of addressing this unmet need with a preventative mRNA vaccine against primary CMV infection,” Stephane Bancel, chief executive officer of Moderna, said in the announcement.
CMV is a virus that remains in the body for life after infection. In adults, initial infection with CMV goes undetected and does not pose a long-term health risk for most healthy individuals, a Moderna spokesperson explained. But for some, it can lead to lifelong medical conditions.
The CDC estimated that about one in 200 babies are born with CMV, and approximately one in five of them will have serious side effects, including hearing loss, seizures, and blindness.
Moderna’s mRNA-1647 combines six mRNAs in one vaccine, two proteins located on the surface of CMV, five mRNAs encoding the subunits that form the membrane-bound pentamer complex, and one mRNA-encoding the full-length membrane-bound glycoprotein B (gB).
Overall, the vaccine is designed to produce an immune response against both the pentamer and gB to prevent CMV infection. Currently, there are no approved vaccines to prevent CMV.
