ACTIVE_NOT_RECRUITING

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

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Conditions

Epstein-Barr Virus InfectionInfectious mononucleosisMononucleosisVirus DiseasesInfectionsGamma-herpesvirus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 Through 55 Years of Age

Quick Facts

Study Start:2023-04-05
Study Completion:2026-10-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05831111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening.
  2. * According to the assessment of the Investigator, is in good general health and can comply with study procedures.
  3. * 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.
  1. * 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.
  2. * 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).
  3. * 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.
  4. * History of myocarditis, pericarditis, or myopericarditis.
  5. * 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.
  6. * 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.
  7. * 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.

Contacts and Locations

Study Locations (Sites)

Pinnacle Research Group, LLC
Anniston, Alabama, 36207
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
Marvel Clinical Research
Huntington Beach, California, 92647
United States
Tekton Research
Longmont, Colorado, 80501
United States
Suncoast Research Group, LLC
Miami, Florida, 33135
United States
Velocity Clinical Research
Savannah, Georgia, 31406
United States
Optimal Research
Peoria, Illinois, 61614
United States
DM Clinical Research- River Forest
River Forest, Illinois, 60305
United States
Velocity Clinical Research
Sioux City, Iowa, 51106
United States
Johnson County Clin-Trials, Inc (JCCT)
Lenexa, Kansas, 66219
United States
Velocity Clinical Research
Rockville, Maryland, 20854
United States
DM Clinical Research
Brookline, Massachusetts, 02445
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
DM Clinical Research
Southfield, Michigan, 48076
United States
Velocity Clinical Research
Grand Island, Nebraska, 68803
United States
Velocity Clinical Research
Hastings, Nebraska, 68901
United States
Velocity Clinical Research
Lincoln, Nebraska, 68510
United States
Velocity Clinical Research
Norfolk, Nebraska, 68701
United States
Velocity Clinical Research
Omaha, Nebraska, 68134
United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030
United States
Velocity Clinical Research
Binghamton, New York, 13905
United States
Rochester Clinical Research, Inc
Rochester, New York, 14609
United States
Eximia Clinical Research
Raleigh, North Carolina, 27607
United States
Tekton Research, Inc
Edmond, Oklahoma, 73013
United States
Tekton Research
Moore, Oklahoma, 73160
United States
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, 73099
United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
United States
Benchmark Research
Austin, Texas, 78705
United States
Tekton Research Inc.
Austin, Texas, 78745
United States
DM Clinical Research
Houston, Texas, 77065
United States
Research Your Health
Plano, Texas, 75093
United States
DM Clinical Research
Sugar Land, Texas, 77478
United States
DM Clinical Research
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05
Study Completion Date2026-10-07

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2026-10-07

Terms related to this study

Keywords Provided by Researchers

  • Infectious mononucleosis
  • Mononucleosis
  • Virus Diseases
  • Infections
  • Gamma-herpesvirus

Additional Relevant MeSH Terms

  • Epstein-Barr Virus Infection