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mRNA-1195

Phase 2

Multiple Sclerosis | Vaccine | Neurology |Moderna, Inc.|Trials Updated: Jun 15, 2026

mRNA-1195 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Apr 2023

mRNA-1195 target and mechanism

Molecular targetEBV
Target classVirus
ModalityVaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

mRNA-1195 clinical trials

mRNA-1195 · 1 trial · 1 indication

Phase 2 1
NCT06735248A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 YearsMultiple Sclerosis
RECRUITING180 Analytics
PHASE2RECRUITING
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 176 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 197 (28 days after each study injection)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Up to Day 347 (up to 6 months after last study injection)
Number of Participants with Adverse Events of Special Interest (AESI), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention and/or Study Participation
Up to Day 887 (end of study)

Secondary Endpoints

Cumulative Number of New Gadolinium (Gd)-enhancing Longitudinal Relaxation Time (T1) Hyperintense Lesions, as Measured by Magnetic Resonance Imaging (MRI) from Baseline to Month 12 and End of Study (Day 887)
Baseline to Month 12 and Day 887 (end of study)
Mean Number of Gd-enhancing T1 Hyperintense Lesions Per Scan, as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)
Baseline to Month 12 and Day 887 (end of study)
Cumulative Number of New and/or Newly Enlarging Transverse Relaxation Time (T2)-weighted Hyperintense Lesions as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)
Baseline to Month 12 and Day 887 (end of study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
mRNA-1195 Dose Level 1 (Low Dose)EXPERIMENTALParticipants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.
mRNA-1195 Dose Level 2 (High Dose)EXPERIMENTALParticipants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
PlaceboPLACEBO_COMPARATORParticipants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.

Interventions

NameTypeDescription
mRNA-1195BIOLOGICALIM injection
PlaceboBIOLOGICALIM injection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring. * Participants who are Epstein-Barr virus (EBV)-seroposit...

Countries:United StatesAustraliaUnited Kingdom
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Frequently asked questions about mRNA-1195

What is mRNA-1195?

mRNA-1195 is an investigational vaccine developed by Moderna, Inc. for multiple sclerosis. It is designed to target Epstein-Barr virus (EBV) and is currently in Phase 2 clinical development. It has not been approved by any regulatory agency and remains an experimental therapy being studied for relapse prevention in people with multiple sclerosis.

What is mRNA-1195 used for in multiple sclerosis?

mRNA-1195 is being studied for relapse prevention in adults with multiple sclerosis. The Phase 2 trial enrolls participants aged 18 to 55 years and compares the vaccine against placebo. Because it is investigational, mRNA-1195 is not yet available as a treatment outside of clinical research.

What does mRNA-1195 target?

mRNA-1195 targets Epstein-Barr virus, or EBV, a virus in the herpesvirus family. The vaccine is designed to generate an immune response against EBV. The Phase 2 study is testing whether targeting EBV with mRNA-1195 can help prevent relapses in people with multiple sclerosis.

Who is developing mRNA-1195?

Moderna, Inc. is developing mRNA-1195. Moderna trades on the Nasdaq under the ticker symbol MRNA. The company is running the Phase 2 multiple sclerosis program, which is currently recruiting participants in the United States, Australia, and the United Kingdom.

What phase is mRNA-1195 in?

mRNA-1195 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory authority. The Phase 2 trial is actively recruiting, and no trials of mRNA-1195 have been completed to date.

What clinical trials is mRNA-1195 in?

mRNA-1195 is being studied in one clinical trial, NCT06735248, titled a study to investigate multiple sclerosis relapse prevention with mRNA-1195 compared with placebo in participants aged 18 to 55 years. The Phase 2 trial is randomized, double-blind, and placebo-controlled, with an planned enrollment of 180 participants across the United States, Australia, and the United Kingdom.