Moderna, Inc., a biotechnology company developing breakthrough messenger RNA (mRNA) therapeutics and vaccines, announced today that it is the first participant in the Phase 1 study of mRNA-1189, Epstein-Barr virus ( EBV) vaccine candidates of the company. The study is known as the Eclipse.
“EBV is one of the most common viral infections in the world, and while it causes infectious mononucleosis that affects millions of young people around the world, no vaccine is currently available. Adolescents with infectious mononucleosis often stay away from school for weeks and even months, which affects the quality of their education and families, “said Stéphane Bancel, Chief Executive Officer of Moderna.
The start of this Phase 1 study is an important milestone as we continue to advance mRNA vaccines against latent viruses that can remain in the body for life after infection and lead to chronic diseases. Moderna is committed to developing a portfolio of world-class vaccines against latent viruses for which there are no approved vaccines today, including vaccines for CMV, EBV and HIV. Our research team is working to bring even more vaccines against latent viruses into the clinic. We believe these vaccines could have a profound impact on the quality of health of hundreds of millions of people around the world. “
Stéphane Bancel, Chief Executive Officer, Moderna
EBV is a common viral infection that affects 83% of Americans by the age of 19 years. It is spread through body fluids (e.g., saliva) and is typically infected in early childhood or adolescence. While EBV infection is mostly asymptomatic in early childhood, a primary infection in adolescence can lead to infectious mononucleosis (IM), a clinical syndrome with fever, fatigue, sore throat and lymphadenopathy. IM can debilitate patients for weeks to months and sometimes hospitalization for serious complications such as ruptured spleen and significant airway impairment. EBV is responsible for approximately 90% of the one million cases of IM annually in the US As a latent virus, EBV remains in the body for life after infection and can lead to lifelong illness, which has significant direct and indirect costs to the health system. EBV is associated with a 4 to 10-fold risk of developing multiple sclerosis and certain lymphoproliferative diseases, cancer, and autoimmune diseases.
Moderna’s vaccine candidate against EBV (mRNA-1189) is being developed to prevent EBV-induced IM and possibly EBV infection. Similar to Moderna’s cytomegalovirus (CMV) vaccine candidate (mRNA-1647), mRNA-1189 contains four mRNAs that encode EBV envelope glycoproteins (gH, gL, gp42, gp220) that enable viral entry into B cells (a type of Immune system) mediate cells) and epithelial surface cells, the main targets of EBV infection. There is currently no approved vaccine for EBV or IM. Potential future indications may be the prevention of EBV reactivation in other types of diseases, such as: B. post-transplant lymphoproliferative disease.
The Phase 1 randomized, observer-blind, placebo-controlled study of mRNA-1189 is being conducted in approximately 15 US locations. The main purpose of the Phase 1 study is to evaluate the safety and tolerability of mRNA-1189 in healthy adults aged 18 to 30. Moderna expects approximately 270 participants. The ClinicalTrials.gov identifier is NCT05164094. To learn more about eligibility, please click here.
Moderna’s mRNA vaccine portfolio includes candidates against respiratory viruses, tropical viruses and latent viruses. Moderna is committed to developing world-class vaccines against latent viruses for which there are no approved vaccines today, including vaccines for EBV, CMV and the human immunodeficiency virus (HIV).
The consequences of this can be serious for people with compromised immune systems or infants born with CMV infection. A pregnant mother with active CMV infection can transmit the virus to her unborn child, resulting in congenital CMV infection, which is the leading infectious cause of birth defects in the United States. The company’s vaccine candidate for CMV (mRNA-1647) is currently being evaluated for safety and efficacy in a Phase 3 study, CMVictory.
HIV is the virus responsible for acquired immune deficiency syndrome (AIDS), a lifelong, progressive disease with no effective cure. There are currently approximately 38 million people living with HIV worldwide, including approximately 1.2 million in the United States. Moderna is developing two vaccine candidates for HIV, including mRNA-1644, in a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation. and mRNA-1574, which is being evaluated in collaboration with the US National Institutes of Health (NIH).