Clinical trial · Interventional
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
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
NCT07478952CI-TRIAL-00106294recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mRNA-1189 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- mRNA-1189 Dose Level 1 (ID)
- description
- Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.
- interventionNames
- Biological: mRNA-1189
- type
- EXPERIMENTAL
- label
- mRNA-1189 Dose Level 2 (ID)
- description
- Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57.
- interventionNames
- Biological: mRNA-1189
- type
- EXPERIMENTAL
- label
- mRNA-1189 Dose Level 1 (IM)
- description
- Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.