A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants

Last updated: May 6, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

mRNA-1189

mRNA-1195.1

mRNA-1195.2

Clinical Study ID

NCT05831111
mRNA-1195-P101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBVserostatus or Positive EBV serostatus at Screening.

  • According to the assessment of the Investigator, is in good general health and cancomply with study procedures.

  • For participants of childbearing potential: negative pregnancy test, adequatecontraception or has abstained from all activities that could result in pregnancyfor at least 28 days prior to Day 1, agreement to continue adequate contraceptionthrough 3 months following last study injection and is not currently breast/chestfeeding.

Exclusion

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.

  • Symptomatic acute or chronic illness requiring ongoing medical or surgical care, toinclude changes in medication in the past 2 months indicating that chronicillness/disease is not stable (at the discretion of the Investigator).

  • Any medical, psychiatric, or occupational condition, including reported history ofdrug or alcohol abuse, that, in the opinion of the Investigator, might poseadditional risk due to participation in the study or could interfere with theinterpretation of study results.

  • History of myocarditis, pericarditis, or myopericarditis.

  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10milligrams [mg]/day of prednisone or equivalent) or is anticipating the need forimmunosuppressive treatment at any time during participation in the study. Topicalcorticosteroids and tacrolimus are allowed.

  • Participant has received or plans to receive any licensed or authorized vaccine, toinclude COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans toreceive a licensed vaccine within 28 days before or after any study injection, withthe exception of licensed/authorized influenza vaccines, which may be received morethan 14 days before or after any study injection.

  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days priorto the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 474
Treatment Group(s): 5
Primary Treatment: mRNA-1189
Phase: 1
Study Start date:
April 05, 2023
Estimated Completion Date:
June 24, 2027

Study Description

There will be 2 sequential parts to the study:

  • Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening.

  • Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Completed

  • West Coast Research

    Dublin, California 94568
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Longmonth Medical Research Network

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Tekton Research

    Longmont, Colorado 80501
    United States

    Active - Recruiting

  • Washington Health Institute

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • Suncoast Research Group, LLC

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Meridian Clinical Research - Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

  • DM Clinical Research- River Forest

    River Forest, Illinois 60305
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research

    Sioux City, Iowa 51106
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Velocity Clinical Research

    Rockville, Maryland 20854
    United States

    Active - Recruiting

  • DM Clinical Research

    Brookline, Massachusetts 02445
    United States

    Active - Recruiting

  • University of Mass Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • DM Clinical Research

    Southfield, Michigan 48076
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Meridian Clinical Research

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Velocity Clinical Research

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Hastings, Nebraska 68901
    United States

    Completed

  • Meridian Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Velocity Clinical Research

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Velocity Clinical Research

    Norfolk, Nebraska 68701
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

  • Las Vegas Clinical Trials, LLC

    Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada 89030
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Binghamton, New York 13905
    United States

    Active - Recruiting

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Eximia Clinical Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Tekton Research, Inc

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Tekton Research

    Moore, Oklahoma 73160
    United States

    Active - Recruiting

  • Tekton Research, Inc - Yukon Location

    Yukon, Oklahoma 73099
    United States

    Active - Recruiting

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Benchmark Research

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Tekton Research Inc.

    Austin, Texas 78745
    United States

    Active - Recruiting

  • CyFair

    Houston, Texas 77065
    United States

    Site Not Available

  • DM Clinical Research

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Research Your Health

    Plano, Texas 75093
    United States

    Active - Recruiting

  • DM Clinical Research

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

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