A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Epstein-Barr Virus Infection

In brief

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.

Key facts

Study ID

NCT05164094

Run by

ModernaTX, Inc.

People needed

867

Starts

2021-12-28

Expected to finish

2027-08-18

Last updated by the study team

2026-05-06

Who can join

Age: 10 and older, up to 30. Sex: any. Healthy volunteers: accepted.

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.
• Note: Other inclusion and exclusion criteria may apply.

Where it is running

• Smart Cures Clinical Research — Anaheim, California, United States
• Benchmark Research - Colton - HyperCore - PPDS — Colton, California, United States
• Fomat Medical Research — Oxnard, California, United States
• Center For Clinical Trials LLC -Paramount — Paramount, California, United States
• Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS — Riverside, California, United States
• Peninsula Research Associates - Headlands Research - PPDS — Rolling Hills, California, United States
• Velocity Clinical Research - Banning - PPDS — San Bernardino, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• California Research Foundation - 4180 Ruffin Rd — San Diego, California, United States
• Orange County Research Center — Tustin, California, United States
• CenExel iResearch, LLC — Hollywood, Florida, United States
• Jacksonville Center For Clinical Research - ERN - PPDS — Jacksonville, Florida, United States
• iResearch Savannah - CenExel - PPDS — Savannah, Georgia, United States
• Velocity Clinical Research - Savannah — Savannah, Georgia, United States
• Clinical Research Atlanta - Headlands - PPDS — Stockbridge, Georgia, United States
• Velocity Clinical Research — Meridian, Idaho, United States
• Olivo Medical and Wellness Center — Chicago, Illinois, United States
• DM Clinical Research — River Forest, Illinois, United States
• Velocity Clinical Research — Valparaiso, Indiana, United States
• Velocity Clinical Research - Sioux City — Sioux City, Iowa, United States
• Alliance for Multispecialty Research, LLC - El Dorado - PPDS — El Dorado, Kansas, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Alliance for Multispecialty Research LLC, East Wichita — Wichita, Kansas, United States
• Michael W Simon MD, PSC — Lexington, Kentucky, United States
• Medical Affiliated Research Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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