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18 June 2019

Lending Our Hands to Help Raise Awareness While Working Toward CMV Prevention

Lori Panther
Director, Clinical Development, VP, Infectious Diseases

During our most recent Town Hall meeting, the Moderna community demonstrated its solidarity by joining the “Stop CMV Hands Campaign.” I’m so proud of my colleagues for lending their hands, as well as their hearts and minds, to advance the science behind Moderna’s mRNA-based vaccine to prevent cytomegalovirus (CMV) infection!

Stop CMV Hands Campaign.

CMV is the most common congenitally transmitted infection worldwide. In the U.S., nearly 40,000 infants are born each year with congenital CMV infection, and 10-15 percent of these infants will have symptoms at birth such as microcephaly, blindness, seizures, hearing loss, jaundice and low birth weight.

Though the majority of congenitally infected infants are asymptomatic at birth, they are at increased risk for cognitive and language developmental delays, seizures and progressive hearing loss. Of note, the major contributor to the overall burden of disease, and the most common complication of congenital CMV infection, is lifelong sensorineural hearing loss.

At particular risk for congenital CMV infection are infants born to mothers who acquire primary CMV infection during pregnancy—approximately one-third of these infants will be born with congenital CMV infection, and the most severe manifestations of infection occur in these infants.

As my colleague Mike Watson shared on this blog in February of last year, primary CMV infection in healthy adults most often goes unnoticed, and women are typically not screened for CMV infection during pregnancy because there is currently no vaccine or treatment. A safe and effective maternal vaccine to prevent congenital CMV infection holds the potential of having a major impact on the health of children worldwide.

We are working to achieve just that, using Moderna’s messenger RNA (mRNA) platform to create a CMV vaccine that directs cells to safely produce and express antigenic proteins that trigger the body’s immune system to produce antibodies that can neutralize the virus and prevent infection.

CMV uses two protein antigens to attach to and enter the body’s cells: one is glycoprotein B, or gB, and the other is a complex protein made of five protein subunits assembled together, called Pentamer. The gB antigen is particularly effective at helping CMV infect fibroblasts, and Pentamer is essential in helping CMV infect epithelial cells (the cells lining our skin, nose and mouth) and endothelial cells.

A vaccine that stimulates strong antibody responses against these antigens is expected to prevent CMV infection, and women protected from CMV infection by such a vaccine would therefore be protected from having a child with congenital CMV infection.

In a study published in Vaccine, Moderna’s mRNA vaccine encoding the CMV antigens gB and Pentamer produced high levels of very specific and durable antibodies that are able to neutralize CMV in mice and non-human primates. These preclinical data demonstrated two powerful findings: an mRNA vaccine encoding five subunit proteins can produce a fully immunogenic Pentamer, and combined with mRNA encoding for gB, produces a multi-valent vaccine that effectively prevented CMV infection across a wide variety of cells.

These exciting findings launched our clinical program to develop our mRNA-1647 CMV vaccine, encoding both gB and Pentamer antigens, for the prevention of primary CMV infection in women of childbearing age. Our first-in-human Phase 1 randomized, observer-blind and placebo-controlled trial to evaluate the safety and immunogenicity of mRNA-1647 vaccine has completed enrollment into the first three dose level cohorts, and the study is enrolling subjects into the fourth dose cohort.

We are excited to show our commitment to the CMV community during National CMV Awareness Month this June—and throughout the year.

Stop CMV people stage

Forward-Looking Statement

This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: whether a maternal vaccine to prevent congenital CMV infection holds the potential of having a major impact on the health of children worldwide; and if a CMV vaccine can neutralize the virus and prevent CMV infection. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: whether preclinical results will be predictive of any future clinical studies, including the ongoing Phase 1 clinical study of mRNA-1647; whether mRNA-1647 will be shown to be unsafe or intolerable during future preclinical or clinical studies; preclinical and clinical development is lengthy and uncertain, especially for a new category of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no mRNA drug has been approved in this new potential category of medicines, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of medicines; and those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained herein in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.