Moderna, Inc. has announced. , a biotech company that is a leading biotech company in mRNA therapies and vaccines, today announced that the first participant underwent doses in a phase 1 study of mRNA-1189, the company’s Epstein-Barr virus (EBV) vaccine candidate. The study is known as an eclipse.
“EBV is one of the most common viral infections in the world, and although it causes infectious mononucleosis, affecting millions of adolescents globally, no vaccine is currently available. Adolescents with mononucleosis often miss school for weeks at a time. “Even months at a time, which affects the quality of their education and their families,” said Stefan Bancel, CEO of Moderna.
The start of this Phase 1 study is a milestone as we continue to develop 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 range 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 more vaccines against latent viruses to the clinic. We believe that these vaccines can have a profound impact on the quality of health of hundreds of millions of people around the world.”
Stefan Bancel, CEO of Moderna
EBV is a common viral infection in 83% of seropositive Americans by age 19. It is spread through body fluids (such as saliva) and is usually transmitted in early childhood or adolescence. While EBV infection in early childhood is often asymptomatic, primary infection in adolescence can lead to infectious mononucleosis (IM), a clinical syndrome that includes fever, fatigue, sore throat, and lymphadenopathy. The muscle can weaken patients for weeks to months, sometimes requiring hospitalization for serious complications such as a ruptured spleen and significant airway obstruction. EBV is responsible for approximately 90% of 1 million cases of muscle injury each year in the United States. As a latent virus, EBV remains in the body for life after infection and can lead to lifelong medical conditions, causing significant direct and indirect costs to the health care system. EBV is associated with a 4- to 10-fold increased risk of developing multiple sclerosis, the development of certain lymphoproliferative disorders, cancers, and autoimmune diseases.
Moderna’s candidate vaccine against EBV (mRNA-1189) is being developed to prevent EBV-induced EBV and potential EBV infection. Similar to Moderna’s cytomegalovirus (CMV) vaccine (mRNA-1647), mRNA-1189 contains four mRNAs that encode EBV envelope glycoproteins (gH, gL, gp42, gp220), which mediate viral entry into B cells (type From the immune system (cells) and surface epithelial cells, which are the main targets of EBV infection. Currently, there is no approved vaccine for EBV or IM. Possible future indications may be prevention of EBV reactivation in other types of conditions such as post-transplant lymphoproliferative disease.
The Phase 1 randomized, blind-controlled, placebo-controlled study of mRNA-1189 will be conducted at approximately 15 sites in the United States. The primary purpose of the Phase 1 study is to evaluate the safety and tolerability of mRNA-1189 in healthy adults aged 18 through 30. Moderna expects to enroll approximately 270 participants. ClinicalTrials.gov’s ID 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 first-class vaccines against latent viruses for which there are no approved vaccines today, including vaccines against EBV, CMV, and human immunodeficiency virus (HIV).
For individuals with weakened immune systems or children born with CMV infection, it can have serious consequences. A pregnant mother with 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 United States. The company’s candidate vaccine against cytomegalovirus (mRNA-1647) is currently being evaluated for safety and efficacy in a phase 3 study, CMVictory.
HIV is the virus responsible for Acquired Immunodeficiency Syndrome (AIDS), a progressive, lifelong disease without effective treatment. Worldwide, there are approximately 38 million people living with HIV, including approximately 1.2 million in the United States. Moderna is developing two candidate HIV vaccines, including mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill & Melinda Gates Foundation, and mRNA-1574, which is being evaluated in collaboration with the US National Institutes of Health (NIH). National Health).