Completed Infection & Immunity NIHR-supported project Cancer

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 early multiple sclerosis

In plain English

AI plain-English summary

A new mRNA vaccine, mRNA-1195, is being tested against a placebo in roughly 180 adults with early multiple sclerosis to see if it can safely train the immune system without triggering a dangerous attack on the brain. This matters because multiple sclerosis is driven by the immune system mistakenly attacking the protective coating around nerve fibres. Existing treatments broadly suppress immunity, leaving patients vulnerable to infections. An mRNA vaccine that specifically targets the rogue immune cells responsible for MS—without shutting down the rest of the immune system—could offer a fundamentally safer and more precise approach. The study is testing two different doses to find the right balance between safety and immune response. If the vaccine works, it could shift MS treatment from lifelong immune suppression to a short course of targeted therapy. That would mean fewer infections, less need for daily medication, and potentially a halt to disease progression in its earliest stages. For a disease that typically strikes young adults and requires decades of management, even a partial success would change the calculus of living with MS.

View original technical description
The purpose of this study is to measure the safety and immunogenicity of mRNA-1195 compared to placebo administered IM in adult participants with “early” MS. Study details include: • The study duration will be up to 30 months. • The treatment duration will be up to 6 months. • The visit frequency will be as presented in the SoA (Table 1 and Table 2). Number of Participants: Approximately 180 participants will be randomized. Study Arms: • mRNA-1195 25 µg • mRNA-1195 50 µg • Placebo

Researchers

Basil Sharrack (Principal Investigator)

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Original classification

Translational Neurosciences

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.