mRNA Epstein-Barr Virus Vaccine Candidate Launches Phase 1 Study

Massachusetts-based Moderna, Inc. today announced the first participant had been dosed in the Eclipse Phase 1 study of mRNA-1189, the Company's Epstein-Barr Virus (EBV) vaccine candidate. 

EBV is a common viral infection with 83% of Americans seropositive by 19 years of age.

mRNA-1189 is being developed to prevent EBV-induced infectious mononucleosis (IM) and potentially EBV infection.

It contains four mRNAs that encode EBV envelope glycoproteins (gH, gL, gp42, gp220), which mediate viral entry into B-cells and epithelial surface cells, the primary targets of EBV infection.

Currently, there is no U.S. FDA Approved vaccine for EBV or IM.

"EBV is one of the most common viral infections in the world, and even though it causes infectious mononucleosis. 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," commented Stéphane Bancel, CEO of Moderna, in a press statement issued on January 5, 2022.

"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."

While EBV infection in early childhood is predominantly asymptomatic, primary infection in adolescence can lead to infectious mononucleosis, which can debilitate patients for weeks to months, sometimes requiring hospitalization for serious complications such as splenic rupture and significant airway compromise.

EBV is spread through bodily fluids (saliva) and is responsible for approximately 90% of the one million cases of IM each year in the U.S.

As a latent virus, EBV remains in the body for life after infection and can lead to lifelong medical conditions, which causes significant direct and indirect costs to the healthcare system.

EBV is associated with a 4- to 10-fold risk of developing multiple sclerosis and development of certain lymphoproliferative disorders, cancers, and autoimmune diseases.