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

September 26, 2025 updated by: ModernaTX, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

482

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • California
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research
    • Colorado
      • Longmont, Colorado, United States, 80501
        • Tekton Research
    • Florida
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Optimal Research
      • River Forest, Illinois, United States, 60305
        • DM Clinical Research- River Forest
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Velocity Clinical Research
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials, Inc (JCCT)
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • DM Clinical Research
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Chan Medical School
    • Michigan
      • Southfield, Michigan, United States, 48076
        • DM Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Velocity Clinical Research
      • Hastings, Nebraska, United States, 68901
        • Velocity Clinical Research
      • Lincoln, Nebraska, United States, 68510
        • Velocity Clinical Research
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials, LLC
    • New York
      • Binghamton, New York, United States, 13905
        • Velocity Clinical Research
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Eximia Clinical Research
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Tekton Research, Inc
      • Moore, Oklahoma, United States, 73160
        • Tekton Research
      • Yukon, Oklahoma, United States, 73099
        • Tekton Research, Inc - Yukon Location
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • DM Clinical Research - Philadelphia
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Austin, Texas, United States, 78745
        • Tekton Research Inc.
      • Houston, Texas, United States, 77065
        • DM Clinical Research
      • Plano, Texas, United States, 75093
        • Research Your Health
      • Sugar Land, Texas, United States, 77478
        • DM Clinical Research
      • Tomball, Texas, United States, 77375
        • DM Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: mRNA-1195.1
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.2
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.1
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.2
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.1
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.2
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.1
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195.2
Sterile liquid for injection
Active Comparator: Part A: mRNA-1189
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Placebo Comparator: Part A: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Placebo Comparator: Part B: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Experimental: 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.
Biological: mRNA-1195
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195
Sterile liquid for injection
Experimental: 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.
Biological: mRNA-1195
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 197 (28-day follow-up after vaccination)
Up to Day 197 (28-day follow-up after vaccination)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame: Up to Day 176 (7-day follow-up after vaccination)
Up to Day 176 (7-day follow-up after vaccination)
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)
Time Frame: Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
Time Frame: Days 1, 85, and 197
Days 1, 85, and 197
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb
Time Frame: Days 1, 85, and 197
Days 1, 85, and 197
Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs
Time Frame: Days 1, 85, and 197
Days 1, 85, and 197

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2023

Primary Completion (Estimated)

October 7, 2026

Study Completion (Estimated)

October 7, 2026

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1195-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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