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Clinical Trials in the USA / NCT05831111
Active, not recruiting Phase 1

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants

NCT05831111 · tracked via the Priya Life Science USA tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 1
Started
2023-04-05
Last updated
2026-08-11

Condition(s) studied

Epstein-Barr Virus Infection

Investigational drug(s) / intervention(s)

mRNA-1195.1mRNA-1195.2mRNA-1189PlacebomRNA-1195

mRNA-1195.1: Sterile liquid for injection

mRNA-1195.2: Sterile liquid for injection

mRNA-1189: Sterile liquid for injection

Placebo: 0.9% sodium chloride (normal saline) injection

mRNA-1195: Sterile liquid for injection

Study summary

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Key Inclusion Criteria: * For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening. * According to the assessment of the Investigator, is in good general health and can comply with study procedures. * For participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following last study injection and is not currently breast/chest feeding. Key Exclusion Criteria: * Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1. * 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). * Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * History of myocarditis, pericarditis, or myopericarditis. * Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed. * Participant 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 injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection. * Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. Note: Other inclusion and exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Pinnacle Research Group, LLC Anniston Alabama
Noble Clinical Research Tucson Arizona
Marvel Clinical Research Huntington Beach California
Tekton Research Longmont Colorado
Suncoast Research Group, LLC Miami Florida
Velocity Clinical Research Savannah Georgia
DM Clinical Research- Chicago Melrose Park Illinois
Optimal Research Peoria Illinois
Velocity Clinical Research Sioux City Iowa
Johnson County Clin-Trials, Inc (JCCT) Lenexa Kansas
Velocity Clinical Research Rockville Maryland
DM Clinical Research Brookline Massachusetts
University of Massachusetts Chan Medical School Worcester Massachusetts
DM Clinical Research Southfield Michigan
Velocity Clinical Research Grand Island Nebraska
Velocity Clinical Research Hastings Nebraska
Velocity Clinical Research Lincoln Nebraska
Velocity Clinical Research Norfolk Nebraska
Velocity Clinical Research Omaha Nebraska
Las Vegas Clinical Trials, LLC North Las Vegas Nevada
Velocity Clinical Research Binghamton New York
Rochester Clinical Research, Inc Rochester New York
Eximia Clinical Research Raleigh North Carolina
Tekton Research, Inc Edmond Oklahoma
Tekton Research Moore Oklahoma
Tekton Research Oklahoma City Oklahoma
DM Clinical Research - Philadelphia Philadelphia Pennsylvania
Alliance for Multispecialty Research, LLC Knoxville Tennessee
Benchmark Research Austin Texas
Tekton Research Inc. Austin Texas
DM Clinical Research Houston Texas
3A Research Plano Texas
DM Clinical Research Sugar Land Texas
DM Clinical Research Tomball Texas

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 NCT05831111 on ClinicalTrials.gov ↗ ← All trials in the USA