A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients

March 14, 2024 updated by: ModernaTX, Inc.

A Phase 2, Observer-Blind, Placebo-Controlled, Proof-of-Concept Trial to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-8344
        • Not yet recruiting
        • UCLA Health - Westwood
      • San Francisco, California, United States, 94143-2202
        • Not yet recruiting
        • UCSF - Infectious Disease Clinic
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33136-1101
        • Not yet recruiting
        • University of Miami, Jackson Memorial Hospital
      • Tampa, Florida, United States, 33606-2707
        • Not yet recruiting
        • Tampa General Medical Group
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Not yet recruiting
        • Piedmont Transplant Institute
    • Illinois
      • Chicago, Illinois, United States, 60611-2945
        • Not yet recruiting
        • Northwestern University, Feinberg School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • University of Kentucky Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2600
        • Not yet recruiting
        • Tulane University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201-1009
        • Not yet recruiting
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287-0020
        • Not yet recruiting
        • Johns Hopkins Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655-0002
        • Recruiting
        • University of Massachusetts Medical School
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Health System
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10032-3720
        • Not yet recruiting
        • Columbia University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207-1248
        • Not yet recruiting
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-2827
        • Not yet recruiting
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania School of Medicine
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Swedish Medical Center
      • Seattle, Washington, United States, 98195-0001
        • Not yet recruiting
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a negative (that is, CMV-seronegative) or a positive (that is, CMV-seropositive) result using a blood IgG assay performed at the central laboratory or a previously documented seropositive result.
  • Listed and anticipated to receive their first deceased donor or living donor liver transplant within 2 months to 12 months of enrollment.
  • A person of nonchildbearing potential, as defined in the protocol.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.

Exclusion Criteria:

  • Listed as "status 1A" for liver transplant.
  • Hypersensitivity to acyclovir, ganciclovir, or valganciclovir.
  • Previous receipt of a solid organ or hematopoietic transplant.
  • Listed for or anticipated to receive an organ transplant other than liver, either simultaneously or sequentially.
  • Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.
  • Suspected or known allergic reaction to any component of any mRNA vaccine, including mRNA-1647, or its excipients.
  • Human immunodeficiency virus (HIV) infection (based on documented testing performed during the transplant evaluation process and no clinical suspicion of HIV infection).
  • Prior (ever) receipt of a stem cell transplant (peripheral blood stem cell, marrow, cord blood).
  • Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mRNA-1647
CMV-seronegative and CMV-seropositive participants will receive 3 intramuscular (IM) injections of mRNA-1647 vaccine on Days 1, 29, and 57.
Biological: mRNA-1647
Sterile liquid for injection
Experimental: Placebo
CMV-seronegative and CMV-seropositive participants will receive 3 IM injections of mRNA-1647 vaccine-matching placebo on Days 1, 29, and 57.
Biological: Placebo
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-transplant: Time to the First Occurrence of a Clinically Significant Cytomegalovirus Infection (CS-CMVi) In Seropositive Participants
Time Frame: Day 373 through Day 466
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
Time Frame: Up to Day 64 (7 days after the last study injection)
Up to Day 64 (7 days after the last study injection)
Number of Participants With Unsolicited Adverse Events
Time Frame: Up to Day 87 (28 days after the last study injection)
Up to Day 87 (28 days after the last study injection)
Number of Participants With Medically Attended Adverse Events
Time Frame: Up to Day 237 (6 months after the last study injection)
Up to Day 237 (6 months after the last study injection)
Number of Participants With Serious Adverse Events
Time Frame: Day 1 through Day 542
Day 1 through Day 542
Number of Participants With Adverse Events of Special Interest
Time Frame: Day 1 through Day 542
Day 1 through Day 542
Number of Participants With Adverse Events Leading to Discontinuation
Time Frame: Day 1 through Day 542
Day 1 through Day 542

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: Day 373 through Day 466
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
Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with Any Occurrence of CMV Viremia
Time Frame: Day 373 through Day 466
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
Time Frame: Day 373 through Day 466
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
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: Time to Initiation of anti-CMV Antiviral Therapy
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: Number of Participants Requiring anti-CMV Antiviral Therapy
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Number of Participants With Investigator-reported CMV Disease
Time Frame: Day 380 through Day 466
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
Time Frame: Day 380 through Day 466
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
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: Duration of Initial CMV Viremia
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: Number of Participants With Recurrent CMV Viremia Following 2 Consecutive Undetectable CMV Viral Load Assays
Time Frame: Day 373 through Day 466
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
Time Frame: Day 373 through Day 466
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
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: CMV Viremia Area Under the Curve
Time Frame: Day 373 through Day 466
Day 373 through Day 466
Post-transplant: Number of Participants With Neutropenia
Time Frame: Day 373 through Day 466
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
Time Frame: Day 365 through Day 466
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
Time Frame: Day 365 through Day 542
Day 365 through Day 542
Post-transplant: All-cause Mortality
Time Frame: Day 365 through Day 542
Day 365 through Day 542
Post-transplant: Number of Participants with Biopsy Proven Allograft Rejection
Time Frame: Day 365 through Day 542
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
Time Frame: Day 1, Day 29, Day 57, Day 87, Day 237, and Day 365
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
Time Frame: Day 365, Day 466, and Day 542
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)
Time Frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
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
Time Frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
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
Time Frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
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
Time Frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • mRNA-1647-P206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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