A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

Last updated: March 12, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Cytomegalovirus Infections

Treatment

mRNA-1647

Placebo

Clinical Study ID

NCT05683457
mRNA-1647-P205
  • Ages > 18
  • All Genders

Study Summary

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.

Eligibility Criteria

Inclusion

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 withpost-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis;or HCT from related or unrelated donor with at least one mismatch at any of thefollowing human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCTfrom related or unrelated donor with myeloablative conditioning.

  • Persons of nonchildbearing potential or of childbearing potential with negativeurine or serum pregnancy test on the day of first study injection.

  • Persons of childbearing potential who have practiced adequate contraception or haveabstained from all activities that could result in pregnancy for at least 28 daysprior to the first dose.

  • Persons of childbearing potential who have agreed to continue adequate contraceptionor abstain from all activities that could result in pregnancy through 3 months afterlast study injection.

  • Persons who are not currently breast/chestfeeding.

  • Willingness to comply with study procedures and provide written informed consent.

Exclusion

Exclusion Criteria:

  • History of a diagnosis or condition that, in the judgment of the Investigator, mayaffect participant safety, assessment of safety endpoints, assessment of immuneresponse, or adherence to study procedures.

  • A documented positive human immunodeficiency virus (HIV) test.

  • Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or anyequivalent in-vivo T cell depleting agent within 12 months.

  • HCT with ex-vivo T cell depletion.

  • Low risk for CMV: HCT from related or unrelated donor with reduced intensityconditioning (RIC) and no other high-risk features.

  • History of prior hematopoietic cell transplantation within 12 months.

  • Receipt of prior investigational CMV vaccines or participation in another CMVtherapeutic study that may interfere with study outcome measures as determined bythe Investigator.

  • Suspected or known allergic reaction to any component of any mRNA vaccine or itsexcipients.

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: mRNA-1647
Phase: 2
Study Start date:
April 05, 2023
Estimated Completion Date:
August 01, 2026

Connect with a study center

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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