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Moderna launches first human test of mRNA vaccine against Epstein-Barr virus

NCT ID NCT05831111

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental mRNA vaccine called mRNA-1195 to see if it is safe and triggers an immune response against Epstein-Barr virus (EBV). The study involves 482 healthy adults aged 18 to 55, some of whom have had EBV before and some who have not. Participants will receive either the vaccine or a placebo, and researchers will monitor for side effects and measure antibody levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1195 (an mRNA vaccine)
What this could lead to
If successful, this could lead to a vaccine that prevents Epstein-Barr virus infection, which is linked to mononucleosis and some cancers.
What could go wrong
This is an early Phase 1 trial focused on safety, so it is too soon to know if the vaccine will work. The study is small and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

482 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening. * 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. Key Exclusion Criteria: * Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees 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, 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. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Infections infectious mononucleosis viral infectious disease Epstein-Barr virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epstein-Barr virus infection

Contacts and locations

Locations

  • 3A Research

    Plano, Texas, 75093, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920, United States

  • Benchmark Research

    Austin, Texas, 78705, United States

  • DM Clinical Research

    Brookline, Massachusetts, 02445, United States

  • DM Clinical Research

    Southfield, Michigan, 48076, United States

  • DM Clinical Research

    Houston, Texas, 77065, United States

  • DM Clinical Research

    Sugar Land, Texas, 77478, United States

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research- Chicago

    Melrose Park, Illinois, 60160, United States

  • Eximia Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa, Kansas, 66219, United States

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada, 89030, United States

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • Optimal Research

    Peoria, Illinois, 61614, United States

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207, United States

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609, United States

  • Suncoast Research Group, LLC

    Miami, Florida, 33135, United States

  • Tekton Research

    Longmont, Colorado, 80501, United States

  • Tekton Research

    Moore, Oklahoma, 73160, United States

  • Tekton Research

    Oklahoma City, Oklahoma, 73134, United States

  • Tekton Research Inc.

    Austin, Texas, 78745, United States

  • Tekton Research, Inc

    Edmond, Oklahoma, 73013, United States

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • Velocity Clinical Research

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research

    Hastings, Nebraska, 68901, United States

  • Velocity Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research

    Binghamton, New York, 13905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.