New trial explores whether EBV vaccine can slow early MS activity
Experimental therapy will be tested over 2.5 years for safety signals
- A Phase 2 trial is testing whether an experimental EBV vaccine is safe in early MS.
- EBV is a key risk factor for multiple sclerosis.
- The vaccine aims to prevent EBV reactivation, which researchers hope could reduce MS activity.
A clinical trial is now recruiting participants to test whether an experimental vaccine for the Epstein-Barr virus (EBV) is safe and may help reduce disease activity in people with multiple sclerosis (MS).
The Phase 2 study (NCT06735248) aims to enroll 180 adults, ages 18 to 55, with relapsing forms of MS who were diagnosed within the past two years, are neurologically stable (as assessed by an investigator), and who are EBV-seropositive at screening. Enrollment is underway at sites in the U.S., the U.K., and Australia.
Participants will receive either a high or low dose of the vaccine, or a placebo, given as three injections into the muscle over a six-month period. Everyone will be monitored for about 2.5 years, with safety as the study’s main focus. Researchers will also look at whether the vaccine affects different measures of MS disease activity.
“This is an important and innovative trial to treat multiple sclerosis by targeting EBV infection using a vaccine,” David Hunt, PhD, an investigator on the trial at the University of Edinburgh, in the U.K., said in a university news story.
Why scientists are targeting EBV in multiple sclerosis
EBV is best known for causing infectious mononucleosis (mono), but it often causes nonspecific childhood illnesses. The majority of people contract EBV at some point, usually before adulthood. Research has shown EBV is a key risk factor for MS.
After infection, EBV can remain dormant in the body’s cells for decades and may reactivate later in life. The experimental vaccine, called mRNA-1195, is designed to prevent this reactivation, which researchers hope could help reduce MS disease activity. The vaccine is being developed by Moderna, which is sponsoring the trial.
“Currently, almost all of our disease-modifying treatments for multiple sclerosis work by suppressing the body’s immune system. The discovery that EBV plays an important role in the development of multiple sclerosis is opening new avenues for treating the condition,” Hunt said.
The vaccine uses mRNA technology — the same platform used for Moderna’s COVID-19 vaccine. Instead of delivering a piece of the virus, mRNA vaccines provide instructions that the body’s cells use to make a small viral protein, training the immune system to recognize the virus and triggering a response similar to traditional vaccines.
The trial, which is expected to conclude in 2029, is open to people with relapsing forms of MS — including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It is also open to people with radiologically isolated syndrome, where MRI scans show MS-like changes before any symptoms appear.
In the U.K., the trial is part of a large-scale collaboration between Moderna and several government and academic partners.
“Not only does this Partnership provide additional resilience to respond more effectively to any future pandemic but also opens doors to working closely with academia to develop new vaccine products for a range of existing health conditions,” said Sarah Collins, director of commercial, vaccines and countermeasures delivery at the UK Health Security Agency.
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