Actively Recruiting
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
Led by ModernaTX, Inc. · Updated on 2026-03-24
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of an Epstein-Barr Virus (EBV) candidate vaccine called mRNA-1189 in healthy adults aged 18 to 30 years. This Phase 1, randomized, open-label study aims to understand how the vaccine performs when delivered through different methods and doses. The study is sponsored by ModernaTX, Inc. and focuses on both local and systemic reactions after vaccination. Participants will receive two injections of the mRNA-1189 vaccine on Days 1 and 57. These injections are administered either intradermally (ID) or intramuscularly (IM) at two different dose levels. Four study groups receive either Dose Level 1 or Dose Level 2 via ID or IM delivery. The vaccine is a sterile liquid designed for injection. During the study, participants will be monitored for adverse reactions and events through Day 225, including solicited local and systemic reactions up to Day 64 and medically attended events up to the study end. Blood samples will be taken on Days 1 and 85 to measure antibody responses, including binding antibody levels and seroconversion rates. The total participation duration extends to approximately 7.5 months to ensure thorough safety and immune response evaluation.
CONDITIONS
Brief Title
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 if not pregnant or breastfeeding.
- Age between 18 and 30 years.
You will not qualify if you...
- Underwent surgical procedures within 7 days before Day 1 or Day 57, or scheduled surgery within 28 days after vaccination.
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- Received corticosteroids at ≥10 mg/day prednisone (or equivalent) for more than 14 days within 90 days before Day 1 or anticipate corticosteroid use during the study.
- Received systemic immunosuppressive treatment including long-acting biologics within 180 days before Day 1 or plan to during the study.
- Received or plan to receive any non-study vaccine from 28 days before first dose to 28 days after second dose.
- History of myocarditis, pericarditis, or myopericarditis before Day 1.
- Previously received an investigational EBV vaccine.
- Other inclusion and exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive two doses of the mRNA-1189 vaccine via intradermal or intramuscular injections on Days 1 and 57.
2 vaccination visits (in-person) on Days 1 and 57
Duration - Up to Day 225 (about 7 months)
Participants are monitored for safety and immune response after vaccination, including adverse reactions and antibody measurements.
Multiple follow-up visits including assessments up to Day 225
Trial Site Locations
Total: 2 locations
1
Nucleus Network
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
2
Doherty Clinical Trials
Melbourne, Victoria, Australia, VIC 3149
Not Yet Recruiting
Research Team
M
Moderna WeCare Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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