A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults
Epstein-Barr Virus Infection
About this trial
This is an interventional prevention trial for Epstein-Barr Virus Infection focused on measuring Infectious mononucleosis, Mononucleosis
Eligibility Criteria
Inclusion Criteria:
- According to the assessment of the investigator, is in good general health and can comply with study procedures.
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).
- Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
- 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.
Sites / Locations
- Medical Affiliated Research InstituteRecruiting
- Care Access Network
- Alliance for Multispecialty Research, LLC
- Smart Cures Clinical ResearchRecruiting
- Velocity Clinical Research - Banning - PPDSRecruiting
- Benchmark Research - Colton - HyperCore - PPDSRecruiting
- Southern California Permanente Medical Group
- Fomat Medical ResearchRecruiting
- Center For Clinical Trials LLC -ParamountRecruiting
- Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
- Peninsula Research Associates - Headlands Research - PPDSRecruiting
- Acclaim Clinical Research
- California Research Foundation - 4180 Ruffin RdRecruiting
- Orange County Research CenterRecruiting
- Research Centers of America - ERG
- Jacksonville Center For Clinical Research - ERN - PPDSRecruiting
- Kissimmee Clinical Research Corp
- University of South Florida
- iResearch Savannah - CenExel - PPDSRecruiting
- Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDSRecruiting
- Clinical Research Atlanta - Headlands - PPDSRecruiting
- Velocity Clinical ResearchRecruiting
- Olivo Medical and Wellness CenterRecruiting
- DM Clinical ResearchRecruiting
- Velocity Clinical ResearchRecruiting
- Meridian Clinical Research, LLCRecruiting
- Alliance for Multispecialty Research, LLC - El Dorado - PPDSRecruiting
- Johnson County Clin-TrialsRecruiting
- Alliance for Multispecialty Research LLC, East WichitaRecruiting
- Michael W Simon MD, PSCRecruiting
- Velocity Clinical Research - Lafayette - PPDSRecruiting
- UMass Memorial Medical CenterRecruiting
- DM Clinical ResearchRecruiting
- Clinical Research Institute, Inc.Recruiting
- Sundance Clinical Research - ERN - PPDSRecruiting
- Meridian Clinical Research (Grand Island, Nebraska)
- Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDSRecruiting
- Quality Clinical Research - ClinEdge - PPDSRecruiting
- Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDSRecruiting
- Meridian Clinical Research, LLC (Lincoln Nebraska)Recruiting
- Alliance for Multispecialty Research, LLC
- Meridian Clinical ResearchRecruiting
- Velocity Clinical Research
- Meridian Clinical ResearchRecruiting
- Lucas ResearchRecruiting
- Lucas ResearchRecruiting
- Meridian Clinical ResearchRecruiting
- Lynn Health Science InstituteRecruiting
- Velocity Clinical Research
- Coastal Pediatric AssociatesRecruiting
- Coastal Carolina Research Center
- Benchmark Research - Austin - PPDSRecruiting
- Tekton Research - Texas - Platinum - PPDS
- ACRC Trials - Hunt - PPDSRecruiting
- Velocity Clinical Research - Austin - PPDSRecruiting
- Cedar Health Research - Fort Worth - PPDSRecruiting
- Benchmark Research - Fort Worth - HyperCore - PPDSRecruiting
- Ventavia Research GroupRecruiting
- DM Clinical Research - Texas Center For Drug Development - ERN - PPDSRecruiting
- DM Clinical Research - Texas Center For Drug Development - ERN - PPDSRecruiting
- ACRC Trials - Legacy Medical Village Headquarters
- ACRC TrialsRecruiting
- Flourish Research - San Antonio - PPDS
- Victoria Clinical Research GroupRecruiting
- Tanner ClinicRecruiting
- Charlottesville Medical Research CenterRecruiting
- Health Research of Hampton Roads Inc. - Newport NewsRecruiting
- Alliance for Multispecialty Research, LLC
- Clinical Research Partners LLC - Richmond - ERN - PPDSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Part A: mRNA-1189 Dose Level 2
Part A: mRNA-1189 Dose Level 3
Part A: mRNA-1189 Dose Level 4
Part A: Placebo
Part B: mRNA-1189 Dose Level 1
Part B: mRNA-1189 Dose Level 2
Part B: mRNA-1189 Dose Level 3
Part B: mRNA-1189 Dose Level 4
Part B: Placebo
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.