Actively Recruiting
Phase 1 Study of the mRNA-1189 Epstein-Barr Virus Vaccine Testing Safety and Immune Response After Skin or Muscle Injection In Healthy Adults Aged 18 to 30 Years
Led by ModernaTX, Inc. · Updated on 2026-03-24
120
Participants Needed
2
Research Sites
N/A
Total Duration
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
Research Team
M
Moderna WeCare Team
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