Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05164094 | A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults | PHASE1 | ACTIVE NOT_RECRUITING | 867 | — | — | Dec 28, 2021 | Aug 18, 2027 | May 6, 2026 | 65 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A: mRNA-1189 Dose Level 2 | EXPERIMENTAL | Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
| Part A: mRNA-1189 Dose Level 3 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
| Part A: mRNA-1189 Dose Level 4 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
| Part B: mRNA-1189 Dose Level 1 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169. |
| Part B: mRNA-1189 Dose Level 2 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
| Part B: mRNA-1189 Dose Level 3 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
| Part B: mRNA-1189 Dose Level 4 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
| Part C: mRNA-1189 Dose Level 1 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169. |
| Part C: mRNA-1189 Dose Level 2 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
| Part C: mRNA-1189 Dose Level 3 | EXPERIMENTAL | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
| Part C: Placebo | PLACEBO_COMPARATOR | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
| Name | Type | Description |
|---|---|---|
| mRNA-1189 | BIOLOGICAL | Sterile liquid for injection |
| Placebo | BIOLOGICAL | 0.9% sodium chloride (normal saline) injection |
Inclusion Criteria: * According to the assessment of the investigator, is in good general health and can comply with study procedures. Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0). Part B: Healthy baseline EBV-seronegative adolescen...