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

Last updated: September 26, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Throat And Tonsil Infections

Treatment

mRNA-1189

mRNA-1195

mRNA-1195.1

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: 482
Treatment Group(s): 5
Primary Treatment: mRNA-1189
Phase: 1
Study Start date:
April 05, 2023
Estimated Completion Date:
October 07, 2026

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

    Site Not Available

  • Pinnacle Research Group, LLC

    Anniston 4830198, Alabama 4829764 36207
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson 5318313, Arizona 5551752 85704
    United States

    Site Not Available

  • West Coast Research

    Dublin, California 94568
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach 5358705, California 5332921 92647
    United States

    Site Not Available

  • Longmonth Medical Research Network

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Tekton Research

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Tekton Research

    Longmont 5579276, Colorado 5417618 80501
    United States

    Site Not Available

  • Washington Health Institute

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • Suncoast Research Group, LLC

    Miami, Florida 33135
    United States

    Site Not Available

  • Suncoast Research Group, LLC

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • Meridian Clinical Research - Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah 4221552, Georgia 4197000 31406
    United States

    Site Not Available

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

  • DM Clinical Research- River Forest

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Optimal Research

    Peoria 4905687, Illinois 4896861 61614
    United States

    Site Not Available

  • DM Clinical Research- River Forest

    River Forest 4907637, Illinois 4896861 60305
    United States

    Site Not Available

  • Meridian Clinical Research

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research

    Sioux City 4876523, Iowa 4862182 51106
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa 4274356, Kansas 4273857 66219
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Velocity Clinical Research

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Velocity Clinical Research

    Rockville 4367175, Maryland 4361885 20854
    United States

    Site Not Available

  • DM Clinical Research

    Brookline, Massachusetts 02445
    United States

    Site Not Available

  • University of Mass Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • DM Clinical Research

    Brookline 4931482, Massachusetts 6254926 02445
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • DM Clinical Research

    Southfield, Michigan 48076
    United States

    Site Not Available

  • DM Clinical Research

    Southfield 5010636, Michigan 5001836 48076
    United States

    Site Not Available

  • 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

    Site Not Available

  • Velocity Clinical Research

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Meridian Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Velocity Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Meridian Clinical Research

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Velocity Clinical Research

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Meridian Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research

    Grand Island 5069297, Nebraska 5073708 68803
    United States

    Site Not Available

  • Velocity Clinical Research

    Hastings 5069802, Nebraska 5073708 68901
    United States

    Site Not Available

  • Velocity Clinical Research

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Site Not Available

  • Velocity Clinical Research

    Norfolk 5073965, Nebraska 5073708 68701
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha 5074472, Nebraska 5073708 68134
    United States

    Site Not Available

  • 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

    Site Not Available

  • Las Vegas Clinical Trials, LLC

    North Las Vegas 5509403, Nevada 5509151 89030
    United States

    Site Not Available

  • Velocity Clinical Research

    Binghamton, New York 13905
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Velocity Clinical Research

    Binghamton 5109177, New York 5128638 13905
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Eximia Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Eximia Clinical Research

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Tekton Research, Inc

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Tekton Research

    Moore, Oklahoma 73160
    United States

    Site Not Available

  • Tekton Research, Inc - Yukon Location

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • Tekton Research, Inc

    Edmond 4535740, Oklahoma 4544379 73013
    United States

    Site Not Available

  • Tekton Research

    Moore 4542975, Oklahoma 4544379 73160
    United States

    Site Not Available

  • Tekton Research, Inc - Yukon Location

    Yukon 4556165, Oklahoma 4544379 73099
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • Benchmark Research

    Austin, Texas 78705
    United States

    Site Not Available

  • 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

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • DM Clinical Research

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Benchmark Research

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Tekton Research Inc.

    Austin 4671654, Texas 4736286 78745
    United States

    Site Not Available

  • DM Clinical Research

    Houston 4699066, Texas 4736286 77065
    United States

    Site Not Available

  • Research Your Health

    Plano 4719457, Texas 4736286 75093
    United States

    Site Not Available

  • DM Clinical Research

    Sugar Land 4734825, Texas 4736286 77478
    United States

    Site Not Available

  • DM Clinical Research

    Tomball 4737094, Texas 4736286 77375
    United States

    Site Not Available

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