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ACTIVE NOT RECRUITING
NCT05164094
PHASE1/PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

867

Start Date

2021-12-28

Completion Date

2026-10-05

Last Updated

2025-05-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

mRNA-1189

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Locations (65)

Medical Affiliated Research Institute

Huntsville, Alabama, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

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

Research Centers of America - ERG

Hollywood, Florida, United States

Jacksonville Center For Clinical Research - ERN - PPDS

Jacksonville, Florida, United States

iResearch Savannah - CenExel - PPDS

Savannah, Georgia, United States

Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS

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

Meridian Clinical Research, LLC

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

Velocity Clinical Research - Lafayette - PPDS

Lafayette, Louisiana, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Great Lakes Research Institute

Southfield, Michigan, United States

DM Clinical Research

Southfield, Michigan, United States

Clinical Research Institute, Inc.

Minneapolis, Minnesota, United States

Sundance Clinical Research - ERN - PPDS

St Louis, Missouri, United States

Meridian Clinical Research (Grand Island, Nebraska)

Grand Island, Nebraska, United States

Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS

Norfolk, Nebraska, United States

Quality Clinical Research - ClinEdge - PPDS

Omaha, Nebraska, United States

Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS

Omaha, Nebraska, United States

Meridian Clinical Research, LLC (Lincoln Nebraska)

Omaha, Nebraska, United States

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, United States

Meridian Clinical Research

Binghamton, New York, United States

Velocity Clinical Research

East Syracuse, New York, United States

Meridian Clinical Research

Endwell, New York, United States

Lucas Research

Morehead City, North Carolina, United States

Lucas Research

New Bern, North Carolina, United States

Meridian Clinical Research

Cincinnati, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Coastal Pediatric Associates

Charleston, South Carolina, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Benchmark Research - Austin - PPDS

Austin, Texas, United States

Tekton Research - Texas - Platinum - PPDS

Austin, Texas, United States

ACRC Trials - Hunt - PPDS

Carrollton, Texas, United States

Velocity Clinical Research - Austin - PPDS

Cedar Park, Texas, United States

Cedar Health Research - Fort Worth - PPDS

Dallas, Texas, United States

Benchmark Research - Fort Worth - HyperCore - PPDS

Fort Worth, Texas, United States

Ventavia Research Group

Houston, Texas, United States

DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

Houston, Texas, United States

DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

Houston, Texas, United States

ACRC Trials - Legacy Medical Village Headquarters

Plano, Texas, United States

ACRC Trials

Plano, Texas, United States

Victoria Clinical Research Group

Victoria, Texas, United States

Tanner Clinic

Layton, Utah, United States

Charlottesville Medical Research Center

Charlottesville, Virginia, United States

Health Research of Hampton Roads Inc. - Newport News

Newport News, Virginia, United States

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, United States

Clinical Research Partners LLC - Richmond - ERN - PPDS

Richmond, Virginia, United States