HORIZON
Research type
Research Study
Full title
A phase 2, randomized, observer-blind, placebo-controlled, dose-ranging study of mRNA-1195 intramuscular injection in participants 18 to ≤55 years of age with multiple sclerosis
IRAS ID
1010420
Contact name
Sailaja Pullela
Contact email
Sponsor organisation
ModernaTX, Inc.
Research summary
ModernaTX, Inc. is sponsoring this research to learn more about a possible treatment for early multiple sclerosis (MS). MS affects the brain and spine, causing vision, movement, and balance problems. Having early MS means a person is experiencing MS-like symptoms for the first time. Researchers think certain viruses, including Epstein-Barr virus (EBV), may play a role in MS development. So, researchers think that developing a vaccine against EBV may help people with MS or at risk of developing MS. There is currently no EBV vaccine available, and treatments for MS do not work well for everyone.
The experimental treatment being studied in this trial is called mRNA-1195.
This trial will include adults aged 18 to 55 years with early MS who test positive for EBV. People with certain medical conditions or who take certain medications may not be able to take part.
Participants will receive either 1 of 2 dose levels of mRNA-1195 or a placebo (an identical treatment with no active ingredients). Treatments will be given as injections into a muscle. Participants will receive their treatment on Day 1, then 2 and 6 months afterwards.The trial will be conducted at sites (hospitals, doctors’ offices, and/or academic medical centers) in multiple countries, including the United Kingdom.
Participants will visit a trial site regularly. Participants will be in the trial for about 2.5 years.
During site visits, trial doctors will keep track of participants’ medical problems and monitor their health using blood tests and magnetic resonance imaging (MRI) scans.
The main goal of the trial is to learn about the safety and reactogenicity of mRNA1195. The reactogenicity of a vaccine describes its potential to cause reactions, such as fever or soreness at the injection site. To do this, researchers will study any medical problems participants have during and after treatment.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0005
Date of REC Opinion
17 Mar 2025
REC opinion
Further Information Favourable Opinion