A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

November 19, 2023 updated by: ModernaTX, Inc.

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults and the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old EBV-seronegative healthy adolescents.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

422

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 Contact

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Institute
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Care Access Network
      • Tempe, Arizona, United States, 85281
        • Alliance for Multispecialty Research, LLC
    • California
      • Anaheim, California, United States, 92806
        • Smart Cures Clinical Research
      • Banning, California, United States, 92220-3082
        • Velocity Clinical Research - Banning - PPDS
      • Colton, California, United States, 92324
        • Benchmark Research - Colton - HyperCore - PPDS
      • Oxnard, California, United States, 93030
        • FOMAT Medical Research
      • Paramount, California, United States, 90723-5459
        • Center For Clinical Trials LLC -Paramount
      • Riverside, California, United States, 92503
        • Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
      • Rolling Hills, California, United States, 90274
        • Peninsula Research Associates - Headlands Research - PPDS
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
      • San Diego, California, United States, 92123-1881
        • California Research Foundation - 4180 Ruffin Rd
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Florida
      • Hollywood, Florida, United States, 33024
        • Research Centers of America - ERG
      • Jacksonville, Florida, United States, 32216-4357
        • Jacksonville Center For Clinical Research - ERN - PPDS
    • Georgia
      • Savannah, Georgia, United States, 31405
        • iResearch Savannah - CenExel - PPDS
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS
      • Stockbridge, Georgia, United States, 30281-9054
        • Clinical Research Atlanta - Headlands - PPDS
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60618-8101
        • Olivo Medical and Wellness Center
      • River Forest, Illinois, United States, 60305
        • DM Clinical Research
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Velocity Clinical Research
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Meridian Clinical Research, LLC
    • Kansas
      • El Dorado, Kansas, United States, 67042-2187
        • Alliance for Multispecialty Research, LLC - El Dorado - PPDS
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research LLC, East Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40517-8379
        • Michael W Simon MD, PSC
    • Louisiana
      • Lafayette, Louisiana, United States, 70508-5173
        • Velocity Clinical Research - Lafayette - PPDS
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center
    • Michigan
      • Southfield, Michigan, United States, 48076
        • DM Clinical Research
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research - ERN - PPDS
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Meridian Clinical Research (Grand Island, Nebraska)
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS
      • Omaha, Nebraska, United States, 68112
        • Quality Clinical Research - ClinEdge - PPDS
      • Omaha, Nebraska, United States, 68510
        • Meridian Clinical Research, LLC (Lincoln Nebraska)
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Alliance for Multispecialty Research, LLC
    • New York
      • Binghamton, New York, United States, 13901
        • Meridian Clinical Research
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research
      • Endwell, New York, United States, 13760
        • Meridian Clinical Research
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research
      • New Bern, North Carolina, United States, 28562
        • Lucas Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Meridian Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research
      • Charleston, South Carolina, United States, 29414-5834
        • Coastal Pediatric Associates
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research - Texas - Platinum - PPDS
      • Austin, Texas, United States, 78705
        • Benchmark Research - Austin - PPDS
      • Carrollton, Texas, United States, 75010
        • ACRC Trials - Hunt - PPDS
      • Cedar Park, Texas, United States, 78613-3936
        • Velocity Clinical Research - Austin - PPDS
      • Dallas, Texas, United States, 75251
        • Cedar Health Research - Fort Worth - PPDS
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research - Fort Worth - HyperCore - PPDS
      • Houston, Texas, United States, 77008
        • Ventavia Research Group
      • Houston, Texas, United States, 77081
        • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
      • Houston, Texas, United States, 77065
        • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
      • Plano, Texas, United States, 75024
        • ACRC Trials
      • Plano, Texas, United States, 75024-4174
        • ACRC Trials - Legacy Medical Village Headquarters
      • Victoria, Texas, United States, 77979
        • Victoria Clinical Research Group
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center
      • Newport News, Virginia, United States, 23606-4537
        • Health Research of Hampton Roads Inc. - Newport News
      • Norfolk, Virginia, United States, 23502
        • Alliance for Multispecialty Research, LLC
      • Richmond, Virginia, United States, 23226-3787
        • Clinical Research Partners LLC - Richmond - ERN - PPDS

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

18 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • According to the assessment of the investigator, is in good general health and can comply with study procedures.

Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Part B:

Healthy adolescent from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).

EBV - seronegative as determined by serology at screening.

Exclusion Criteria:

  • Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.
  • Has 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).
  • Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
  • Has a history of myocarditis, and/or pericarditis.
  • 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 vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: mRNA-1189 Dose Level 2
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Experimental: Part A: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Experimental: Part A: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Placebo Comparator: Part A: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Experimental: Part B: mRNA-1189 Dose Level 1
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Experimental: Part B: mRNA-1189 Dose Level 2
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Experimental: Part B: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Experimental: Part B: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Biological: mRNA-1189
Sterile liquid for injection
Placebo Comparator: Part B: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Biological: Placebo
0.9% sodium chloride (normal saline) 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 Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs)
Time Frame: Day 1 to end of study (EOS) (Day 505)
Day 1 to end of study (EOS) (Day 505)
Number of Participants with Laboratory Abnormalities
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 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
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 Antigen-Specific bAb
Time Frame: Days 1, 85, and 197
Days 1, 85, and 197
Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs
Time Frame: Days 1, 85, and 197
The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with > 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.
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)

December 28, 2021

Primary Completion (Estimated)

June 18, 2025

Study Completion (Estimated)

June 18, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1189-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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