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Epstein-Barr Virus InfectionPhase 1NCT05831111

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

A Phase 1 study testing mRNA-1195.1, mRNA-1195.2 and mRNA-1189 in people with Epstein-Barr Virus Infection, run by ModernaTX, Inc. at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Epstein-Barr Virus Infection
What is being tested?
mRNA-1195.1, mRNA-1195.2 and mRNA-1189
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
482 participants
Where
34 sitesUnited States
Study dates
5 Apr 2023to 14 Oct 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research Inc.

    Austin, Texas, 78745

  • Velocity Clinical Research

    Binghamton, New York, 13905

  • DM Clinical Research

    Brookline, Massachusetts, 02445

  • Tekton Research, Inc

    Edmond, Oklahoma, 73013

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research

    Hastings, Nebraska, 68901

  • DM Clinical Research

    Houston, Texas, 77065

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa, Kansas, 66219

  • Velocity Clinical Research

    Lincoln, Nebraska, 68510

  • Tekton Research

    Longmont, Colorado, 80501

  • DM Clinical Research- Chicago

    Melrose Park, Illinois, 60160

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Tekton Research

    Moore, Oklahoma, 73160

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada, 89030

  • Tekton Research

    Oklahoma City, Oklahoma, 73134

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Optimal Research

    Peoria, Illinois, 61614

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • 3A Research

    Plano, Texas, 75093

  • Eximia Clinical Research

    Raleigh, North Carolina, 27607

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Velocity Clinical Research

    Rockville, Maryland, 20854

  • Velocity Clinical Research

    Savannah, Georgia, 31406

  • Velocity Clinical Research

    Sioux City, Iowa, 51106

  • DM Clinical Research

    Southfield, Michigan, 48076

  • DM Clinical Research

    Sugar Land, Texas, 77478

  • DM Clinical Research

    Tomball, Texas, 77375

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 Through 55 Years of Age

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

Read the detailed 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.
Being tested
mRNA-1195.1, mRNA-1195.2, mRNA-1189, Placebo, mRNA-1195
Keywords
Infectious mononucleosis, Mononucleosis, Virus Diseases, Infections, Gamma-herpesvirus
Medical subject headings
Epstein-Barr Virus Infections, Infectious Mononucleosis, Virus Diseases, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1195.1Biological

    Sterile liquid for injection

  • mRNA-1195.2Biological

    Sterile liquid for injection

  • mRNA-1189Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

  • mRNA-1195Biological

    Sterile liquid for injection

Study groups in NCT05831111
Study groupRoleWhat they receive
Part A: mRNA-1195.1 Dose Level 1ExperimentalParticipants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 1ExperimentalParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 2ExperimentalParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 2ExperimentalParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 3ExperimentalParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 3ExperimentalParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 4ExperimentalParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 4ExperimentalParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Receives: Biological: mRNA-1195.2
Part A: mRNA-1189Active comparatorParticipants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part A: PlaceboPlacebo comparatorParticipants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Receives: Biological: Placebo
Part B: PlaceboPlacebo comparatorParticipants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Receives: Biological: Placebo
Part B: mRNA-1195 Low DoseExperimentalParticipants 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.
Receives: Biological: mRNA-1195
Part B: mRNA-1195 Middle DoseExperimentalParticipants 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.
Receives: Biological: mRNA-1195
Part B: mRNA-1195 High DoseExperimentalParticipants 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.
Receives: Biological: mRNA-1195

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Measured: Up to Day 176 (7-day follow-up after vaccination)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Measured: Up to Day 197 (28-day follow-up after vaccination)

  3. Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs)

    Measured: Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)

Secondary outcomes (3)

  1. Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)

    Measured: Days 1, 85, and 197

  2. Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb

    Measured: Days 1, 85, and 197

  3. Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs

    Measured: Days 1, 85, and 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start5 Apr 2023
  3. Primary completion14 Oct 2026
  4. Study completion14 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831111
Sponsor's protocol ID
mRNA-1195-P101
Status last verified
Oct 2026
First submitted
14 Apr 2023
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1195.1, mRNA-1195.2 and mRNA-1189 in people with Epstein-Barr Virus Infection, run by ModernaTX, Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to Day 176 (7-day follow-up after vaccination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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