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mRNA-1189 · 2 trials · 2 indications
| 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. |
| mRNA-1189 Dose Level 1 (ID) | EXPERIMENTAL | Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
| mRNA-1189 Dose Level 2 (ID) | EXPERIMENTAL | Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
| mRNA-1189 Dose Level 1 (IM) | EXPERIMENTAL | Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
| mRNA-1189 Dose Level 2 (IM) | EXPERIMENTAL | Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
| 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...
mRNA-1189 is an investigational vaccine developed by Moderna, Inc. for the prevention of Epstein-Barr Virus (EBV) infection. It is an mRNA-based candidate designed to protect against EBV, a virus that causes infectious mononucleosis and is associated with certain cancers and autoimmune conditions. It remains in clinical development and is not approved for use.
mRNA-1189 is being studied to prevent Epstein-Barr Virus infection in healthy adolescents and adults. Clinical trials have enrolled healthy volunteers aged 10 to 30 years, including a Phase 1 study of 867 participants in the United States and a separate Phase 1 study of 120 healthy adults aged 18 to 30 in Australia.
mRNA-1189 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine candidate in healthy adolescent and adult volunteers.
mRNA-1189 is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been conducted, one of which is currently recruiting and the other active but not recruiting.
mRNA-1189 has been evaluated in two Phase 1 trials. NCT05164094 studied the vaccine in 10- to 30-year-old healthy adolescents and adults across the United States and is active but not recruiting. NCT07478952 is a recruiting Phase 1 study in healthy adults aged 18 to 30 in Australia.
Clinical trials of mRNA-1189 have enrolled a total of 867 participants. The Phase 1 study NCT05164094 accounts for all 867 of those participants, while the currently recruiting Phase 1 study NCT07478952 plans to enroll 120 healthy adults aged 18 to 30 in Australia.