The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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)-seropositive at screening.
* Participants diagnosed with relapsing multiple sclerosis, including those with a single clinical attack (that is, clinically isolated syndrome \[CIS\]), as well as participants diagnosed with radiologically isolated syndrome, within 24 months of Screening Visit (that is, early in their multiple sclerosis course) and in the opinion of the Investigator have been neurologically stable for at least 30 days prior to Visit 1/Day 1.
* A participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding and using a highly effective contraceptive method.
Exclusion Criteria:
* Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 Fahrenheit °F\]) within 72 hours prior to or at screening or Day 1.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \[COVID-19\] regardless of vaccine type) within 28 days before or after any study injection, or within 14 days before or after any study injection for the influenza vaccine.
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent)
* Participants with any documented history of myocarditis, pericarditis, or myopericarditis.
* Has donated ≥450 milliliter (mL) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection.
Note: Other inclusion and exclusion criteria may apply.
Primary outcome measure(s)
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)
Trial sites (17)
Facility
City
Region
Status
Boston Clinical Trials Inc - Internal Medicine
Boston
Massachusetts
Terminated
Quest Research Institute
Farmington Hills
Michigan
Recruiting
Sharlin Health & Neurology
Ozark
Missouri
Terminated
Washington University School of Medicine Neurology Clinical Unit
St Louis
Missouri
Recruiting
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Oklahoma City
Oklahoma
Recruiting
University of Texas Southwestern Medical Center
Dallas
Texas
Recruiting
ANESC Research
El Paso
Texas
Recruiting
Saturn Research Solutions
Plano
Texas
Recruiting
University of the Sunshine Coast Clinical Trials
Birtinya
Queensland
Recruiting
North Bristol NHS Trust - Southmead Hospital
Bristol
United Kingdom
Recruiting
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff
United Kingdom
Recruiting
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Edinburgh
United Kingdom
Recruiting
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
Glasgow
United Kingdom
Recruiting
Cambridge Clinical Research Centre
London
United Kingdom
Recruiting
East Kent Hospitals University NHS Foundation Trust
London
United Kingdom
Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
United Kingdom
Recruiting
Sheffield Teaching Hospital NHS foundation Trust, Herries Road
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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