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Trial was cancelled by Sponsor
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The purpose of this study is to assess the effect of pre-transplant mRNA-1647 on post-transplant cytomegalovirus (CMV) virologic outcomes, anti-CMV antiviral use, and clinical outcomes in CMV-seropositive and CMV-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity, and immunogenicity of mRNA-1647 in all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1647 | Experimental | CMV-seronegative and CMV-seropositive participants will receive 3 intramuscular (IM) injections of mRNA-1647 vaccine on Days 1, 29, and 57. |
|
| Placebo | Experimental | CMV-seronegative and CMV-seropositive participants will receive 3 IM injections of mRNA-1647 vaccine-matching placebo on Days 1, 29, and 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1647 | Biological | Sterile liquid for injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Post-transplant: Time to the First Occurrence of a Clinically Significant Cytomegalovirus Infection (CS-CMVi) In Seropositive Participants | CS-CMVi will be defined as CMV viremia necessitating treatment (with treatment initiated at viral load ≥250 international units/milliliter [IU/mL] and/or CMV disease) through Day 466. | Day 373 through Day 466 |
| Number of Participants With Solicited Local and Systemic Adverse Reactions | Up to Day 64 (7 days after the last study injection) | |
| Number of Participants With Unsolicited Adverse Events | Up to Day 87 (28 days after the last study injection) | |
| Number of Participants With Medically Attended Adverse Events | Up to Day 237 (6 months after the last study injection) | |
| Number of Participants With Serious Adverse Events | Day 1 through Day 542 | |
| Number of Participants With Adverse Events of Special Interest | Day 1 through Day 542 | |
| Number of Participants With Adverse Events Leading to Discontinuation | Day 1 through Day 542 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-transplant: Time to First Occurrence of Adjudicated CMV Disease in Seronegative Participants Who Receive a Liver Transplant from a CMV-seropositive Donor | Evidence of adjudicated CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence. | Day 373 through Day 466 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D006561 | Herpes Simplex |
| D014777 | Virus Diseases |
| D004266 | DNA Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
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| ID | Term |
|---|---|
| C000722750 | mRNA-1647 cytomegalovirus vaccine |
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| Biological |
Sterile liquid for injection |
|
| Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with Any Occurrence of CMV Viremia |
Viremia will be defined as any detectable viral load through Day 466. |
| Day 373 through Day 466 |
| Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with an Occurrence of CMV Viremia | Viremia will be defined as a viral load ≥1000 IU/mL through Day 466. | Day 373 through Day 466 |
| Post-transplant: Duration of anti-CMV Antiviral Therapy | Day 373 through Day 466 |
| Post-transplant: Time to Initiation of anti-CMV Antiviral Therapy | Day 373 through Day 466 |
| Post-transplant: Number of Participants Requiring anti-CMV Antiviral Therapy | Day 373 through Day 466 |
| Number of Participants With Investigator-reported CMV Disease | Evidence of CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence. | Day 380 through Day 466 |
| Number of Seropositive Participants With CMV Disease, Defined as Adjudicated CMV Disease | Evidence of adjudicated CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence. Adjudication will occur by a blinded adjudication committee per protocol. | Day 380 through Day 466 |
| Post-transplant: Time to Onset of Initial CMV Viremia | Day 373 through Day 466 |
| Post-transplant: Duration of Initial CMV Viremia | Day 373 through Day 466 |
| Post-transplant: Number of Participants With Recurrent CMV Viremia Following 2 Consecutive Undetectable CMV Viral Load Assays | Recurrent CMV viremia will be defined as a viral load ≥250 IU/mL for seropositive participants and any detectable level for seronegative participants who receive a seropositive organ. | Day 373 through Day 466 |
| Post-transplant: Duration of Recurrent CMV Viremia | Recurrent CMV viremia will be defined as a viral load ≥250 IU/mL for seropositive participants and any detectable level for seronegative participants who receive a seropositive organ | Day 373 through Day 466 |
| Post-transplant: Peak Viral Load in Participants with CMV Viremia | Day 373 through Day 466 |
| Post-transplant: CMV Viremia Area Under the Curve | Day 373 through Day 466 |
| Post-transplant: Number of Participants With Neutropenia | Neutropenia will be defined as an absolute neutrophil count ≤500 absolute neutrophils/microliter. | Day 373 through Day 466 |
| Post-transplant: Number of Participants With Leukopenia on 2 Successive Measurements Separated by at Least 24 Hours | Leukopenia will be defined as an absolute white blood cells (WBC) <3500 cells/cubic milliliter (mm^3) if baseline was ≥4000 cells/mm^3 or a decrease in WBC of >20% if the baseline count was <4000 cells/mm^3. | Day 365 through Day 466 |
| Post-transplant: Number of Participants Requiring Liver Re-transplantation | Day 365 through Day 542 |
| Post-transplant: All-cause Mortality | Day 365 through Day 542 |
| Post-transplant: Number of Participants with Biopsy Proven Allograft Rejection | Biopsy proven allograft rejection will be adjudicated by a blinded adjudication committee per protocol. | Day 365 through Day 542 |
| Pre-transplant: Titer of CMV- Specific Neutralizing Antibody (nAb) as Measured by Cell-based Neutralization Assay | Day 1, Day 29, Day 57, Day 87, Day 237, and Day 365 |
| Post-transplant: Titer of CMV-Specific nAb Post-transplant as Measured by Cell-based Neutralization Assay | Day 365, Day 466, and Day 542 |
| Pre- and Post-transplant: Geometric Mean Titer (GMT) of Anti-glycoprotein B (gB)-specific Immunoglobulin G (IgG) and Antipentamer-specific IgG as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542 |
| Pre- and Post-transplant: Geometric Mean Concentration (GMC) of Anti-gB-specific IgG and Antipentamer-specific IgG as Measured by ELISA | Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542 |
| Pre- and Post-transplant: Geometric Mean Ratio (GMR) of Post-baseline/Baseline GMTs and GMCs | Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542 |
| Pre- and Post-transplant: Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline GMTs or GMCs | Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542 |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |