Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1647 · 6 trials · 2 indications
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z \* the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
| Arm | Type | Description |
|---|---|---|
| mRNA-1647 | EXPERIMENTAL | Participants will receive mRNA-1647 by intramuscular (IM) injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive mRNA-1647 matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180. |
| Primary Extension Phase | OTHER | CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202. |
| Optional Booster Phase - BD Recipients | EXPERIMENTAL | Participants who opted to enroll into the optional Booster Phase will receive a single mRNA-1647 vaccine dose. |
| Optional Booster Phase - Observational Group | OTHER | Participants who opted to enroll into the Observational Group will be followed in the optional BP until BP Month 12. |
| mRNA-1647 Dose Level A | EXPERIMENTAL | Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection on Day 1, Day 56, and Day 168. |
| mRNA-1647 Dose Level B | EXPERIMENTAL | Participants will receive mRNA-1647 vaccine at Dose Level B by IM injection on Day 1, Day 56, and Day 168. |
| mRNA-1647 Dose Level C | EXPERIMENTAL | Participants will receive mRNA-1647 vaccine at Dose Level C by IM injection on Day 1, Day 56, and Day 168. |
| mRNA-1647 Dose A | EXPERIMENTAL | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level A by intramuscular (IM) injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
| mRNA-1647 Dose B | EXPERIMENTAL | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level B by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
| mRNA-1647 Dose C | EXPERIMENTAL | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age and 16 to 25 years of age will receive mRNA-1647 at Dose Level C by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
| Dose Expansion: mRNA-1647 (3-dose Schedule) | EXPERIMENTAL | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
| Dose Expansion: mRNA-1647 (2-dose Schedule) | EXPERIMENTAL | CMV-seronegative participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 2-injection series on Day 1 and Month 6. |
| Dose Expansion: Placebo (3-dose Schedule) | PLACEBO_COMPARATOR | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive placebo by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
| Dose Expansion: Placebo (2-dose Schedule) | PLACEBO_COMPARATOR | CMV-seronegative participants 9 to 15 years of age will receive placebo by IM injection given as a 2-injection series on Day 1 and Month 6. |
| mRNA-1443 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mRNA-1647 | BIOLOGICAL | Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline). |
| Placebo | BIOLOGICAL | 0.9% sodium chloride (normal saline) injection |
| mRNA-1443 | BIOLOGICAL | Escalating dose levels |
Inclusion Criteria: * Receipt of an allogeneic HCT. * CMV-seropositive, defined as a documented positive test for anti-CMV IgG. * High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT fr...
mRNA-1647 is an investigational vaccine developed by Moderna, Inc. (ticker MRNA) for cytomegalovirus, also known as CMV. It is designed to prevent cytomegalovirus infection and is being studied in both healthy participants and in allogeneic hematopoietic cell transplantation recipients.
mRNA-1647 is being developed to prevent cytomegalovirus infection. Clinical studies have enrolled healthy participants, including adolescents and young adults, as well as allogeneic hematopoietic cell transplantation recipients, a population at elevated risk from CMV. It remains investigational and has not been approved for use.
Moderna, Inc., which trades on Nasdaq under the ticker MRNA, is the developer of mRNA-1647. The company sponsors the clinical program evaluating the vaccine in cytomegalovirus indications across multiple study sites in the United States, Canada, and the United Kingdom.
mRNA-1647 is in clinical development and is investigational. Its trial program spans Phase 1 and Phase 2 studies, with five trials recorded in total: four completed and one currently active but not recruiting. The active study is a Phase 2 trial in allogeneic hematopoietic cell transplantation participants.
The active trial is NCT05683457, a Phase 2 study of mRNA-1647 in allogeneic hematopoietic cell transplantation participants. Completed studies include NCT05575492, a Phase 1 trial in healthy participants aged 9 to 25, NCT05105048, a Phase 1 study, and NCT04975893, a long-term extension study.
Across the recorded mRNA-1647 clinical trials, total enrollment is 873 participants. The largest study, NCT05575492, accounts for all 873 of those participants and was a Phase 1 trial in healthy individuals aged 9 to 25 years conducted in the United States, Canada, and the United Kingdom.