A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
1 other identifier
interventional
867
1 country
65
Brief Summary
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, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2021
Longer than P75 for phase_1
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedStudy Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2027
May 6, 2026
May 1, 2026
4.8 years
December 1, 2021
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
Day 1 to end of study (EOS) (Day 505)
Number of Participants with Laboratory Abnormalities
Up to Day 176 (7-day follow-up after vaccination)
Secondary Outcomes (4)
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb)
Days 1, 85, and 197
Geometric Mean Concentration (GMC) of Antigen-specific Binding Antibody (bAb)
Days 1, 85, and 197
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-specific bAb
Days 1, 85, and 197
Number of Participants with Seroresponse of B-Cell nAbs and Antigen-specific bAbs
Days 1, 85, and 197
Study Arms (13)
Part A: mRNA-1189 Dose Level 2
EXPERIMENTALParticipants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Part A: mRNA-1189 Dose Level 3
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Part A: mRNA-1189 Dose Level 4
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Part A: Placebo
PLACEBO COMPARATORParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Part B: mRNA-1189 Dose Level 1
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Part B: mRNA-1189 Dose Level 2
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Part B: mRNA-1189 Dose Level 3
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Part B: mRNA-1189 Dose Level 4
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Part B: Placebo
PLACEBO COMPARATORParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Part C: mRNA-1189 Dose Level 1
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Part C: mRNA-1189 Dose Level 2
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Part C: mRNA-1189 Dose Level 3
EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Part C: Placebo
PLACEBO COMPARATORParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Interventions
Sterile liquid for injection
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
You may qualify if:
- 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 baseline EBV-seronegative adolescents from 12 to \<18 years of age at the time of consent (Screening Visit, Day 0).
- Part C:
- Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (65)
Medical Affiliated Research Institute
Huntsville, Alabama, 35801, United States
Smart Cures Clinical Research
Anaheim, California, 92806, United States
Benchmark Research - Colton - HyperCore - PPDS
Colton, California, 92324, United States
Fomat Medical Research
Oxnard, California, 93030, United States
Center For Clinical Trials LLC -Paramount
Paramount, California, 90723-5459, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
Riverside, California, 92503, United States
Peninsula Research Associates - Headlands Research - PPDS
Rolling Hills, California, 90274, United States
Velocity Clinical Research - Banning - PPDS
San Bernardino, California, 92220-3082, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
California Research Foundation - 4180 Ruffin Rd
San Diego, California, 92123-1881, United States
Orange County Research Center
Tustin, California, 92780, United States
CenExel iResearch, LLC
Hollywood, Florida, 33024, United States
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida, 32216-4357, United States
iResearch Savannah - CenExel - PPDS
Savannah, Georgia, 31405, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta - Headlands - PPDS
Stockbridge, Georgia, 30281-9054, United States
Velocity Clinical Research
Meridian, Idaho, 83642, United States
Olivo Medical and Wellness Center
Chicago, Illinois, 60618-8101, United States
DM Clinical Research
River Forest, Illinois, 60305, United States
Velocity Clinical Research
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106, United States
Alliance for Multispecialty Research, LLC - El Dorado - PPDS
El Dorado, Kansas, 67042-2187, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Alliance for Multispecialty Research LLC, East Wichita
Wichita, Kansas, 67207, United States
Michael W Simon MD, PSC
Lexington, Kentucky, 40517-8379, United States
Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana, 70508-5173, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
DM Clinical Research
Southfield, Michigan, 48076, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Sundance Clinical Research - ERN - PPDS
St Louis, Missouri, 63141, United States
Velocity Clinical Research - Grand Island
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research - Lincoln
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701, United States
Quality Clinical Research - ClinEdge - PPDS
Omaha, Nebraska, 68112, United States
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, 13901, United States
Velocity Clinical Research
East Syracuse, New York, 13057, United States
Velocity Clinical Research - Vestal
Vestal, New York, 13850, United States
Lucas Research
Morehead City, North Carolina, 28557, United States
Lucas Research
New Bern, North Carolina, 28562, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Velocity Clinical Research
Anderson, South Carolina, 29621, United States
Coastal Pediatric Associates
Charleston, South Carolina, 29414-5834, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Benchmark Research - Austin - PPDS
Austin, Texas, 78705, United States
Tekton Research - Texas - Platinum - PPDS
Austin, Texas, 78745, United States
ACRC Trials - Hunt - PPDS
Carrollton, Texas, 75010, United States
Velocity Clinical Research - Austin - PPDS
Cedar Park, Texas, 78613-3936, United States
Cedar Health Research - Fort Worth - PPDS
Dallas, Texas, 75251, United States
Benchmark Research - Fort Worth - HyperCore - PPDS
Fort Worth, Texas, 76135, United States
ACRC Trials
Frisco, Texas, 75024, United States
Helios Clinical Research
Houston, Texas, 77008, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
Houston, Texas, 77065, United States
ACRC Trials - Legacy Medical Village Headquarters
Plano, Texas, 75024-4174, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
Tomball, Texas, 77375, United States
Victoria Clinical Research Group
Victoria, Texas, 77979, United States
Tanner Clinic
Layton, Utah, 84041, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911, United States
Health Research of Hampton Roads Inc. - Newport News
Newport News, Virginia, 23606-4537, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502, United States
Clinical Research Partners LLC - Richmond - ERN - PPDS
Richmond, Virginia, 23226-3787, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 20, 2021
Study Start
December 28, 2021
Primary Completion (Estimated)
October 5, 2026
Study Completion (Estimated)
August 18, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05