mRNA-1189 Epstein-Barr (EBV) vaccine in healthy adults 18 to 30

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial enrolls healthy adults aged 18 to 30 who receive mRNA-1189 by intradermal or intramuscular injection. Dosing visits are timed around Day 1 and Day 57 with scheduled follow-up visits to monitor participants. The primary outcomes are safety (adverse events) and immunogenicity measured by antibody and cellular immune responses. The trial is sponsored by Moderna and conducted at two clinical sites in Melbourne, Australia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nucleus Network
  Melbourne, Victoria, Australia Recruiting
• Doherty Clinical Trials
  Melbourne, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Moderna WeCare Team
• Email: WeCareClinicalTrials@modernatx.com
• Phone: 1-866-663-3762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.