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

Description

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

Conditions

Epstein-Barr Virus Infection

Study Overview

Study Details

Study overview

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

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

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

Condition
Epstein-Barr Virus Infection
Intervention / Treatment

-

Contacts and Locations

Anniston

Pinnacle Research Group, LLC, Anniston, Alabama, United States, 36207

Tucson

Noble Clinical Research, Tucson, Arizona, United States, 85704

Dublin

West Coast Research, Dublin, California, United States, 94568

Huntington Beach

Marvel Clinical Research, Huntington Beach, California, United States, 92647

Longmont

Tekton Research, Longmont, Colorado, United States, 80501

Washington

Washington Health Institute, Washington, District of Columbia, United States, 20017

Miami

Suncoast Research Group, LLC, Miami, Florida, United States, 33135

Savannah

Velocity Clinical Research, Savannah, Georgia, United States, 31406

Peoria

Optimal Research, Peoria, Illinois, United States, 61614

River Forest

DM Clinical Research- River Forest, River Forest, Illinois, United States, 60305

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ModernaTX, Inc.,

Study Record Dates

2027-06-24