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NCT Number: NCT07478952

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age

The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.

Recruiting

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Doherty Clinical Trials, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy as determined by medical evaluation including medical history and physical examination.
  • Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.

Exclusion criteria

  • Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
  • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
  • Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
  • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
  • Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day 57.
  • History of myocarditis, pericarditis, or myopericarditis prior to Day 1.
  • Has previously received an investigational EBV vaccine.

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

mRNA-1189

Biological

Sterile liquid for injection

Primary outcomes

  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time frame: Up to Day 64 (7-day follow-up after vaccination)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Up to Day 85 (28-day follow-up after vaccination)

  3. Number of Participants with Medically Attended Adverse Events (MAAEs)

    Time frame: Day 1 up to Day 225

  4. Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)

    Time frame: Day 1 to end of study (EOS) (Day 225)

Secondary outcomes

  1. Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)

    Time frame: Days 1 and 85

  2. Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb

    Time frame: Day 85

  3. Number of Participants With Seroconversion of Antigen-Specific bAbs

    Time frame: Day 85

Study contacts

Contact information is provided by the study sponsor or research team.

Moderna WeCare Team

CONTACT

[email protected]

1-866-663-3762

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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