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

NCT06133010 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: mRNA-1647-P206
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cytomegalovirus Infection

Keywords

mRNA-1647; Vaccine; Liver Transplant; CMV; Human Herpesvirus; Cytomegalovirus Vaccine; Cytomegalovirus Infections; Cytomegalovirus Disease; Cytomegalovirus; Virus Disease; Infection Viral; DNA Virus Infections; Messenger RNA

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (25)

• Post-transplant: Time to First Occurrence of Adjudicated CMV Disease in Seronegative Participants Who Receive a Liver Transplant from a CMV-seropositive Donor

  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

  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

  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

Study Arms (2)

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.

Biological: mRNA-1647

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.

Biological: Placebo

Interventions

mRNA-1647 BIOLOGICAL

Sterile liquid for injection

mRNA-1647

Placebo BIOLOGICAL

Sterile liquid for injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

MeSH Terms

Conditions

Cytomegalovirus Infections; Herpes Simplex; Virus Diseases; DNA Virus Infections

Interventions

mRNA-1647 cytomegalovirus vaccine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03