| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05683457 | A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants. | PHASE2 | ACTIVE NOT_RECRUITING | 84 | — | — | Apr 5, 2023 | Aug 1, 2026 | May 18, 2026 | 3 | United States |
| NCT04975893 | A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine | PHASE2 | COMPLETED | 135 | — | — | Jun 18, 2021 | Jan 19, 2026 | Feb 2, 2026 | 7 | United States |
| NCT04232280 | Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults | PHASE2 | COMPLETED | 315 | — | — | Jan 9, 2020 | Jan 4, 2023 | May 5, 2026 | 9 | United States |
| NCT05105048 | A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 | PHASE1 | COMPLETED | 9 | — | — | Nov 8, 2021 | Aug 10, 2023 | Sep 11, 2023 | 3 | United States |
| NCT03382405 | Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults | PHASE1 | COMPLETED | 181 | — | — | Nov 13, 2017 | Oct 28, 2020 | Jan 15, 2021 | 4 | United States |
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.
| 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-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...