Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1189 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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: * 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:...
mRNA-1189 is an investigational messenger RNA (mRNA) vaccine being developed for the prevention of Epstein-Barr Virus (EBV) infection. It is currently in Phase 1 clinical trials studying healthy adolescents and adults. The vaccine is designed to target EBV, the virus that causes infectious mononucleosis and is associated with certain cancers.
mRNA-1189 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ exchange. Moderna is conducting clinical trials of this EBV candidate vaccine in the United States and Australia.
mRNA-1189 is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 1 trials are ongoing, one in the United States and one in Australia, studying the vaccine in healthy adolescents and adults.
mRNA-1189 is being studied in two Phase 1 clinical trials. The first, NCT05164094, is an active but not recruiting study in the United States enrolling 867 healthy adolescents and adults aged 10 to 30 years. The second, NCT07478952, is recruiting 120 healthy adults aged 18 to 30 years in Australia.
mRNA-1189 is an mRNA vaccine that works by instructing cells to produce a viral protein that triggers an immune response against Epstein-Barr Virus. This approach aims to generate protective antibodies and immune memory to prevent EBV infection. The vaccine is administered to healthy individuals to elicit immunity.
mRNA-1189 is a specific mRNA-based vaccine candidate developed by Moderna for Epstein-Barr Virus. It is not the same as other EBV vaccines in development, which may use different technologies such as protein subunits or viral vectors. mRNA-1189 is unique to Moderna's pipeline.