In a recent press release, the manufacturer, Moderna, announced the first participant has been dosed in the phase I study, known as Eclipse, for its novel EBV vaccine candidate, mRNA-1189.
Stéphane Bancel, CEO of Moderna, stated, "EBV is one of the most common viral infections in the world, and despite the fact that it causes infectious mononucleosis [IM], which impacts millions of adolescents globally, no vaccine is currently available. Adolescents who develop infectious mononucleosis are frequently absent from school for weeks and even months at a time, impacting the quality of their education and their families."
The CEO also stated, "The start of this Phase 1 study is a significant milestone as we continue to advance mRNA vaccines against latent viruses, which remain in the body for life after infection and can lead to chronic medical conditions. Moderna is committed to developing a portfolio of first-in-class vaccines against latent viruses for which there are no approved vaccines today, including vaccines against CMV, EBV and HIV. Our research team is working to bring even more vaccines against latent viruses to the clinic. We believe these vaccines could have a profound impact on quality of health for hundreds of millions of people around the world."
Moderna's vaccine candidate against EBV is being developed to prevent EBV-induced infectious mononucleosis (IM) and, potentially, EBV infection. Comparable to Moderna's cytomegalovirus (CMV) vaccine candidate (mRNA-1647), mRNA-1189 is comprised of four mRNAs that encode EBV envelope glycoproteins (gH, gL, gp42, and gp220), which mediate viral entry into B-cells and epithelial surface cells—the major targets of EBV infection. Currently, there is no approved vaccine for EBV or IM. Moreover, other potential future indications may be the prevention of EBV reactivation in other types of conditions such as posttransplant lymphoproliferative disease.
The phase I randomized, observer-blind, placebo-controlled study of mRNA-1189 will be conducted at approximately 15 sites in the U.S.; the principal purpose of this study is to evaluate safety and tolerability of mRNA-1189 in healthy adults aged 18 to 30 years. Moderna expects to enroll nearly 270 participants. The ClinicalTrials.gov identifier is NCT05164094. More information regarding the eligibility requirements for this trial can be found here.
To date, Moderna's mRNA vaccine portfolio includes candidates against respiratory, tropical, and latent viruses. The manufacturer is committed to developing first-in-class vaccines against latent viruses for which there are no approved vaccines, including vaccines against EBV, CMV, and HIV.
For individuals with weakened immune systems or infants born with CMV infection, it can have serious consequences. A pregnant mother with an active CMV infection may pass the virus to her unborn child, resulting in congenital CMV infection, which is the leading infectious cause of birth defects in the U.S. Moderna's vaccine candidate against CMV is currently being evaluated for safety and efficacy in a phase III study. More information can be found at CMVictory.
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