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Testing a new mRNA vaccine for Epstein-Barr Virus in healthy adults

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

Phase 1 Interventional ModernaTX, Inc. · NCT05831111

This study is testing a new mRNA vaccine for Epstein-Barr Virus in healthy adults aged 18 to 55 to see if it is safe and what side effects it might cause.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment474 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorModernaTX, Inc. Industry-sponsored
Drugs / interventionsprednisone
Locations40 sites (Anniston, Alabama and 39 other locations)
Trial IDNCT05831111 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and reactogenicity of the mRNA-1195 vaccine in healthy participants aged 18 to 55. It consists of two parts: Part A enrolls EBV-seropositive individuals, while Part B includes both EBV-seronegative and seropositive participants aged 18 to 30. Participants will receive either the vaccine or a placebo, and their health will be monitored throughout the study to assess any adverse reactions.

Who should consider this trial

Good fit: Ideal candidates are healthy individuals aged 18 to 55, with specific EBV serostatus requirements depending on the study part.

Not a fit: Patients with acute illnesses or chronic conditions requiring ongoing medical care may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a preventive measure against Epstein-Barr Virus infections, potentially reducing the incidence of related diseases.

How similar studies have performed: While there have been studies on EBV vaccines, this mRNA approach is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anniston, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Epstein-Barr Virus InfectionInfectious mononucleosisMononucleosisVirus DiseasesInfectionsGamma-herpesvirus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.