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

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

This trial will test whether the mRNA-1189 vaccine is safe and triggers an immune response in healthy adults 18 to 30 when given into the skin or muscle.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 30 Years
• Sex: All
• Sponsor: ModernaTX, Inc. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Melbourne, Victoria and 1 other locations)
• Trial ID: NCT07478952 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults aged 18 to 30 who are not pregnant or breastfeeding and meet the study's medical criteria are the intended participants.

Not a fit: People who are immunocompromised, recently had or are planning recent major surgery, are on recent or ongoing immunosuppressive therapy, are pregnant or breastfeeding, or are outside the 18–30 age range are unlikely to be eligible or to benefit from this early-phase trial.

Why it matters

Potential benefit: If successful, mRNA-1189 could induce protective immunity against Epstein-Barr virus and help prevent EBV-related illness.

How similar studies have performed: Traditional EBV vaccine approaches have shown limited success and mRNA-based EBV vaccines are a novel, early-stage approach with no proven efficacy yet.

Eligibility criteria

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 this trial is running

Melbourne, Victoria and 1 other locations

• Nucleus Network — Melbourne, Victoria, Australia (Recruiting)
• Doherty Clinical Trials — Melbourne, Victoria, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Moderna WeCare Team

Conditions Epstein-Barr Virus