A clinical trial is currently enrolling participants aged 10-21 to evaluate an investigational mRNA vaccine, mRNA-1189, designed to prevent infection by the Epstein-Barr Virus (EBV) and the associated illness, infectious mononucleosis (mono). Senders Pediatrics in South Euclid, Ohio, is one of the trial sites for the Eclipse Trial, a study conducted in conjunction with Moderna.
The Eclipse Trial: Investigating mRNA-1189
The Eclipse Trial aims to assess the safety and immune response of the mRNA-1189 vaccine. Participants will be randomly assigned to receive one of three dose levels of the vaccine or a saltwater placebo. The trial spans approximately 19 months, including a screening period, a dosing period consisting of three injections, and a follow-up observation period. Participants will use an electronic diary to report any side effects and will participate in phone call appointments to monitor their health.
The Burden of EBV and Mono
EBV is highly contagious, with approximately 90% of people in the U.S. infected by age 35. While many infections are subclinical, those who contract EBV in late adolescence or early adulthood often experience severe symptoms of mono, including fatigue, sore throat, fever, and swollen lymph nodes. According to Dr. Shelly Senders, Founder and CEO of Senders Pediatrics, more than 3 million cases of mono are diagnosed annually in the U.S.
Broader Implications of EBV Prevention
Beyond preventing mono, eliminating EBV could have significant implications for reducing the risk of several autoimmune disorders. "EBV is linked to seven autoimmune disorders, including lupus, multiple sclerosis, rheumatoid arthritis, type 1 diabetes, celiac disease and inflammatory bowel disease, which affect over 8 million Americans," Senders stated. Research suggests that a protein called EBNA2, produced by EBV, binds to regions of human genes associated with these conditions.
mRNA Vaccine Technology
The mRNA-1189 vaccine utilizes messenger RNA (mRNA) technology, similar to that used in some COVID-19 vaccines. mRNA vaccines deliver instructions to cells to produce antigens, triggering an immune response without causing disease. Senders explained that mRNA vaccines skip the DNA to mRNA step, leading to a quicker development of immunity. He also noted that mRNA technology is not new and is not expected to be any less safe than getting the natural disease itself.
Trial Details and Future Outlook
The Eclipse Trial began in 2021, and the goal is to complete clinical trials by the end of 2026 or the beginning of 2027, with licensure potentially following about a year later. If successful, the mRNA-1189 vaccine would be administered preemptively to prevent EBV infection, similar to vaccines for measles, mumps, rubella, and chickenpox. Participants in the trial will receive the investigational vaccine and trial-related procedures at no charge and will be compensated for their time. Insurance is not needed to join the clinical trial, and participants have the right to withdraw at any time.
