A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults

Last updated: March 7, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Placebo

mRNA-1189

Clinical Study ID

NCT05164094
mRNA-1189-P101
  • Ages 10-30
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Part B:

Healthy baseline EBV-seronegative adolescents from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).

Part C:

Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Exclusion

Exclusion Criteria:

  • Has had significant exposure to someone with severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to thescreening visit, if the participant has not been fully vaccinated against COVID-19at least 14 days prior to the screening visit.

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

  • Significant, progressive, unstable or uncontrolled clinical condition, including anycondition that may affect participant safety, assessment of study endpoints,assessment of immune response, or adherence to study procedures per investigatorjudgement.

  • Has a history of myocarditis, and/or pericarditis.

  • Has received or plans to receive any licensed or authorized vaccine, to includeCOVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receivea licensed vaccine within 28 days before or after any study vaccine injection, withthe exception of licensed influenza vaccines, which may be received more than 14days before or after any study vaccine injection.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 842
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
December 28, 2021
Estimated Completion Date:
October 05, 2026

Connect with a study center

  • Medical Affiliated Research Institute

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Care Access Network

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Smart Cures Clinical Research

    Anaheim, California 92806
    United States

    Active - Recruiting

  • Velocity Clinical Research - Banning - PPDS

    Banning, California 92220-3082
    United States

    Site Not Available

  • Benchmark Research - Colton - HyperCore - PPDS

    Colton, California 92324
    United States

    Active - Recruiting

  • Southern California Permanente Medical Group

    Los Angeles, California 90027-5209
    United States

    Site Not Available

  • Fomat Medical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Center For Clinical Trials LLC -Paramount

    Paramount, California 90723-5459
    United States

    Active - Recruiting

  • Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS

    Riverside, California 92503
    United States

    Active - Recruiting

  • Peninsula Research Associates - Headlands Research - PPDS

    Rolling Hills, California 90274
    United States

    Active - Recruiting

  • Velocity Clinical Research - Banning - PPDS

    San Bernardino, California 92220-3082
    United States

    Active - Recruiting

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • California Research Foundation - 4180 Ruffin Rd

    San Diego, California 92123-1881
    United States

    Active - Recruiting

  • Orange County Research Center

    Tustin, California 92780
    United States

    Active - Recruiting

  • Research Centers of America - ERG

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Jacksonville Center For Clinical Research - ERN - PPDS

    Jacksonville, Florida 32216-4357
    United States

    Active - Recruiting

  • Kissimmee Clinical Research Corp

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612-3803
    United States

    Site Not Available

  • Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • iResearch Savannah - CenExel - PPDS

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Clinical Research Atlanta - Headlands - PPDS

    Stockbridge, Georgia 30281-9054
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Olivo Medical and Wellness Center

    Chicago, Illinois 60618-8101
    United States

    Site Not Available

  • DM Clinical Research

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Velocity Clinical Research

    Valparaiso, Indiana 46383
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC - El Dorado - PPDS

    El Dorado, Kansas 67042-2187
    United States

    Active - Recruiting

  • Johnson County Clin-Trials

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research LLC, East Wichita

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Michael W Simon MD, PSC

    Lexington, Kentucky 40517-8379
    United States

    Active - Recruiting

  • Velocity Clinical Research - Lafayette - PPDS

    Lafayette, Louisiana 70508-5173
    United States

    Active - Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • DM Clinical Research

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Great Lakes Research Institute

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • Sundance Clinical Research - ERN - PPDS

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Meridian Clinical Research (Grand Island, Nebraska)

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS

    Norfolk, Nebraska 68701
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC (Lincoln Nebraska)

    Omaha, Nebraska 68510
    United States

    Active - Recruiting

  • Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

  • Quality Clinical Research - ClinEdge - PPDS

    Omaha, Nebraska 68112
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Binghamton, New York 13901
    United States

    Active - Recruiting

  • Velocity Clinical Research

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Endwell, New York 13760
    United States

    Active - Recruiting

  • Lucas Research

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Lucas Research

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Senders Pediatrics

    South Euclid, Ohio 44121
    United States

    Active - Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Velocity Clinical Research

    Anderson, South Carolina 29621
    United States

    Completed

  • Coastal Pediatric Associates

    Charleston, South Carolina 29414-5834
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Benchmark Research - Austin - PPDS

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Tekton Research - Texas - Platinum - PPDS

    Austin, Texas 78745
    United States

    Active - Recruiting

  • ACRC Trials - Hunt - PPDS

    Carrollton, Texas 75010
    United States

    Active - Recruiting

  • Velocity Clinical Research - Austin - PPDS

    Cedar Park, Texas 78613-3936
    United States

    Active - Recruiting

  • Cedar Health Research - Fort Worth - PPDS

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Benchmark Research - Fort Worth - HyperCore - PPDS

    Fort Worth, Texas 76135
    United States

    Active - Recruiting

  • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Ventavia Research Group

    Houston, Texas 77008
    United States

    Active - Recruiting

  • ACRC Trials

    Plano, Texas 75024
    United States

    Active - Recruiting

  • ACRC Trials - Legacy Medical Village Headquarters

    Plano, Texas 75024-4174
    United States

    Active - Recruiting

  • Flourish Research - San Antonio - PPDS

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Victoria Clinical Research Group

    Victoria, Texas 77979
    United States

    Active - Recruiting

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Charlottesville Medical Research Center

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Health Research of Hampton Roads Inc. - Newport News

    Newport News, Virginia 23606-4537
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Clinical Research Partners LLC - Richmond - ERN - PPDS

    Richmond, Virginia 23226-3787
    United States

    Active - Recruiting

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