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Clinical Trials in the USA / NCT05164094
Active, not recruiting Phase 1/2

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

NCT05164094 · tracked via the Priya Life Science USA tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 1/2
Started
2021-12-28
Last updated
2026-05-06

Condition(s) studied

Epstein-Barr Virus Infection

Investigational drug(s) / intervention(s)

mRNA-1189Placebo

mRNA-1189: Sterile liquid for injection

Placebo: 0.9% sodium chloride (normal saline) injection

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
30 Years
Healthy volunteers
Accepted
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 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). 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.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Medical Affiliated Research Institute Huntsville Alabama
Smart Cures Clinical Research Anaheim California
Benchmark Research - Colton - HyperCore - PPDS Colton California
Fomat Medical Research Oxnard California
Center For Clinical Trials LLC -Paramount Paramount California
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS Riverside California
Peninsula Research Associates - Headlands Research - PPDS Rolling Hills California
Velocity Clinical Research - Banning - PPDS San Bernardino California
Acclaim Clinical Research San Diego California
California Research Foundation - 4180 Ruffin Rd San Diego California
Orange County Research Center Tustin California
CenExel iResearch, LLC Hollywood Florida
Jacksonville Center For Clinical Research - ERN - PPDS Jacksonville Florida
iResearch Savannah - CenExel - PPDS Savannah Georgia
Velocity Clinical Research - Savannah Savannah Georgia
Clinical Research Atlanta - Headlands - PPDS Stockbridge Georgia
Velocity Clinical Research Meridian Idaho
Olivo Medical and Wellness Center Chicago Illinois
DM Clinical Research River Forest Illinois
Velocity Clinical Research Valparaiso Indiana
Velocity Clinical Research - Sioux City Sioux City Iowa
Alliance for Multispecialty Research, LLC - El Dorado - PPDS El Dorado Kansas
Johnson County Clin-Trials Lenexa Kansas
Alliance for Multispecialty Research LLC, East Wichita Wichita Kansas
Michael W Simon MD, PSC Lexington Kentucky
Velocity Clinical Research - Lafayette - PPDS Lafayette Louisiana
UMass Memorial Medical Center Worcester Massachusetts
Great Lakes Research Institute Southfield Michigan
DM Clinical Research Southfield Michigan
Clinical Research Institute, Inc. Minneapolis Minnesota
Sundance Clinical Research - ERN - PPDS St Louis Missouri
Velocity Clinical Research - Grand Island Grand Island Nebraska
Velocity Clinical Research - Lincoln Lincoln Nebraska
Velocity Clinical Research - Norfolk Norfolk Nebraska
Quality Clinical Research - ClinEdge - PPDS Omaha Nebraska
Velocity Clinical Research - Omaha Omaha Nebraska
Alliance for Multispecialty Research, LLC Las Vegas Nevada
Velocity Clinical Research - Binghamton Binghamton New York
Velocity Clinical Research East Syracuse New York
Velocity Clinical Research - Vestal Vestal New York

+ 25 more sites — see the full list on the official registry below.

More ModernaTX, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05164094 on ClinicalTrials.gov ↗ ← All trials in the USA