A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
NCT ID: NCT05164094
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
867 participants
INTERVENTIONAL
2021-12-28
2026-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part A: mRNA-1189 Dose Level 2
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part A: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part A: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part A: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Placebo
0.9% sodium chloride (normal saline) injection
Part B: mRNA-1189 Dose Level 1
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part B: mRNA-1189 Dose Level 2
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part B: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part B: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part B: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Placebo
0.9% sodium chloride (normal saline) injection
Part C: mRNA-1189 Dose Level 1
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part C: mRNA-1189 Dose Level 2
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part C: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part C: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
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mRNA-1189
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
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 Criteria
* Has symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator).
* Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
* Has a history of myocarditis, and/or pericarditis.
* Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.
10 Years
30 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Medical Affiliated Research Institute
Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Smart Cures Clinical Research
Anaheim, California, United States
Benchmark Research - Colton - HyperCore - PPDS
Colton, California, United States
Fomat Medical Research
Oxnard, California, United States
Center For Clinical Trials LLC -Paramount
Paramount, California, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
Riverside, California, United States
Peninsula Research Associates - Headlands Research - PPDS
Rolling Hills, California, United States
Velocity Clinical Research - Banning - PPDS
San Bernardino, California, United States
Acclaim Clinical Research
San Diego, California, United States
California Research Foundation - 4180 Ruffin Rd
San Diego, California, United States
Orange County Research Center
Tustin, California, United States
Research Centers of America - ERG
Hollywood, Florida, United States
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida, United States
iResearch Savannah - CenExel - PPDS
Savannah, Georgia, United States
Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS
Savannah, Georgia, United States
Clinical Research Atlanta - Headlands - PPDS
Stockbridge, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Olivo Medical and Wellness Center
Chicago, Illinois, United States
DM Clinical Research
River Forest, Illinois, United States
Velocity Clinical Research
Valparaiso, Indiana, United States
Meridian Clinical Research, LLC
Sioux City, Iowa, United States
Alliance for Multispecialty Research, LLC - El Dorado - PPDS
El Dorado, Kansas, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Alliance for Multispecialty Research LLC, East Wichita
Wichita, Kansas, United States
Michael W Simon MD, PSC
Lexington, Kentucky, United States
Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Great Lakes Research Institute
Southfield, Michigan, United States
DM Clinical Research
Southfield, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Sundance Clinical Research - ERN - PPDS
St Louis, Missouri, United States
Meridian Clinical Research (Grand Island, Nebraska)
Grand Island, Nebraska, United States
Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
Norfolk, Nebraska, United States
Quality Clinical Research - ClinEdge - PPDS
Omaha, Nebraska, United States
Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS
Omaha, Nebraska, United States
Meridian Clinical Research, LLC (Lincoln Nebraska)
Omaha, Nebraska, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
Meridian Clinical Research
Binghamton, New York, United States
Velocity Clinical Research
East Syracuse, New York, United States
Meridian Clinical Research
Endwell, New York, United States
Lucas Research
Morehead City, North Carolina, United States
Lucas Research
New Bern, North Carolina, United States
Meridian Clinical Research
Cincinnati, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Benchmark Research - Austin - PPDS
Austin, Texas, United States
Tekton Research - Texas - Platinum - PPDS
Austin, Texas, United States
ACRC Trials - Hunt - PPDS
Carrollton, Texas, United States
Velocity Clinical Research - Austin - PPDS
Cedar Park, Texas, United States
Cedar Health Research - Fort Worth - PPDS
Dallas, Texas, United States
Benchmark Research - Fort Worth - HyperCore - PPDS
Fort Worth, Texas, United States
Ventavia Research Group
Houston, Texas, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
Houston, Texas, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
Houston, Texas, United States
ACRC Trials - Legacy Medical Village Headquarters
Plano, Texas, United States
ACRC Trials
Plano, Texas, United States
Victoria Clinical Research Group
Victoria, Texas, United States
Tanner Clinic
Layton, Utah, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, United States
Health Research of Hampton Roads Inc. - Newport News
Newport News, Virginia, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States
Clinical Research Partners LLC - Richmond - ERN - PPDS
Richmond, Virginia, United States
Countries
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Other Identifiers
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mRNA-1189-P101
Identifier Type: -
Identifier Source: org_study_id
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