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

NCT05831111 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: mRNA-1195-P101
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Epstein-Barr Virus Infection

Keywords

Infectious mononucleosis; Mononucleosis; Virus Diseases; Infections; Gamma-herpesvirus

Outcome Measures

Primary Outcomes (3)

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

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

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 197 (28-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)

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

Secondary Outcomes (3)

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

  Days 1, 85, and 197

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

  Days 1, 85, and 197

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

  Days 1, 85, and 197

Study Arms (14)

Part A: mRNA-1195.1 Dose Level 1

EXPERIMENTAL

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

Part A: mRNA-1195.2 Dose Level 1

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Part A: mRNA-1195.1 Dose Level 2

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Part A: mRNA-1195.2 Dose Level 2

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Part A: mRNA-1195.1 Dose Level 3

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Part A: mRNA-1195.2 Dose Level 3

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Part A: mRNA-1195.1 Dose Level 4

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Part A: mRNA-1195.2 Dose Level 4

EXPERIMENTAL

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Part A: mRNA-1189

ACTIVE COMPARATOR

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Biological: mRNA-1189

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.

Biological: Placebo

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.

Biological: Placebo

Part B: mRNA-1195 Low Dose

EXPERIMENTAL

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

Part B: mRNA-1195 Middle Dose

EXPERIMENTAL

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

Part B: mRNA-1195 High Dose

EXPERIMENTAL

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

Interventions

mRNA-1195.1 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1195.1 Dose Level 1; Part A: mRNA-1195.1 Dose Level 2; Part A: mRNA-1195.1 Dose Level 3; Part A: mRNA-1195.1 Dose Level 4

mRNA-1195.2 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1195.2 Dose Level 1; Part A: mRNA-1195.2 Dose Level 2; Part A: mRNA-1195.2 Dose Level 3; Part A: mRNA-1195.2 Dose Level 4

mRNA-1189 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1189

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Part A: Placebo; Part B: Placebo

mRNA-1195 BIOLOGICAL

Sterile liquid for injection

Part B: mRNA-1195 High Dose; Part B: mRNA-1195 Low Dose; Part B: mRNA-1195 Middle Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (34)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Tekton Research

Longmont, Colorado, 80501, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Velocity Clinical Research

Savannah, Georgia, 31406, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

DM Clinical Research- River Forest

River Forest, Illinois, 60305, United States

Location

Velocity Clinical Research

Sioux City, Iowa, 51106, United States

Location

Johnson County Clin-Trials, Inc (JCCT)

Lenexa, Kansas, 66219, United States

Location

Velocity Clinical Research

Rockville, Maryland, 20854, United States

Location

DM Clinical Research

Brookline, Massachusetts, 02445, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

DM Clinical Research

Southfield, Michigan, 48076, United States

Location

Velocity Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research

Hastings, Nebraska, 68901, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

Velocity Clinical Research

Binghamton, New York, 13905, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Eximia Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Tekton Research, Inc

Edmond, Oklahoma, 73013, United States

Location

Tekton Research

Moore, Oklahoma, 73160, United States

Location

Tekton Research, Inc - Yukon Location

Yukon, Oklahoma, 73099, United States

Location

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Tekton Research Inc.

Austin, Texas, 78745, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Infectious Mononucleosis; Virus Diseases; Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Tumor Virus Infections; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (34)