A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants
NCT ID: NCT05831111
Last Updated: 2025-09-30
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
482 participants
INTERVENTIONAL
2023-04-05
2026-10-07
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Part A: mRNA-1195.1 Dose Level 1
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
mRNA-1195.1
Sterile liquid for injection
Part A: mRNA-1195.2 Dose Level 1
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
mRNA-1195.2
Sterile liquid for injection
Part A: mRNA-1195.1 Dose Level 2
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
mRNA-1195.1
Sterile liquid for injection
Part A: mRNA-1195.2 Dose Level 2
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
mRNA-1195.2
Sterile liquid for injection
Part A: mRNA-1195.1 Dose Level 3
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
mRNA-1195.1
Sterile liquid for injection
Part A: mRNA-1195.2 Dose Level 3
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
mRNA-1195.2
Sterile liquid for injection
Part A: mRNA-1195.1 Dose Level 4
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
mRNA-1195.1
Sterile liquid for injection
Part A: mRNA-1195.2 Dose Level 4
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
mRNA-1195.2
Sterile liquid for injection
Part A: mRNA-1189
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
mRNA-1189
Sterile liquid for injection
Part A: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Placebo
0.9% sodium chloride (normal saline) injection
Part B: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Placebo
0.9% sodium chloride (normal saline) injection
Part B: mRNA-1195 Low Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
mRNA-1195
Sterile liquid for injection
Part B: mRNA-1195 Middle Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
mRNA-1195
Sterile liquid for injection
Part B: mRNA-1195 High Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
mRNA-1195
Sterile liquid for injection
Interventions
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mRNA-1195.1
Sterile liquid for injection
mRNA-1195.2
Sterile liquid for injection
mRNA-1189
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1195
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* According to the assessment of the Investigator, is in good general health and can comply with study procedures.
* For participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following last study injection and is not currently breast/chest feeding.
Exclusion Criteria
* 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).
* 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.
* 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 ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed.
* Participant 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 injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
18 Years
55 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Noble Clinical Research
Tucson, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
Tekton Research
Longmont, Colorado, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Velocity Clinical Research
Savannah, Georgia, United States
Optimal Research
Peoria, Illinois, United States
DM Clinical Research- River Forest
River Forest, Illinois, United States
Velocity Clinical Research
Sioux City, Iowa, United States
Johnson County Clin-Trials, Inc (JCCT)
Lenexa, Kansas, United States
Velocity Clinical Research
Rockville, Maryland, United States
DM Clinical Research
Brookline, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
DM Clinical Research
Southfield, Michigan, United States
Velocity Clinical Research
Grand Island, Nebraska, United States
Velocity Clinical Research
Hastings, Nebraska, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States
Velocity Clinical Research
Binghamton, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Eximia Clinical Research
Raleigh, North Carolina, United States
Tekton Research, Inc
Edmond, Oklahoma, United States
Tekton Research
Moore, Oklahoma, United States
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Tekton Research Inc.
Austin, Texas, United States
DM Clinical Research
Houston, Texas, United States
Research Your Health
Plano, Texas, United States
DM Clinical Research
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Countries
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Other Identifiers
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mRNA-1195-P101
Identifier Type: -
Identifier Source: org_study_id
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