RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Observer-Blind, Placebo-Controlled Proof-of-Concept Trial to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Patients Who Have Undergone Allogeneic Hematopoietic Cell Transplantation (HCT)

Quick Facts

Study Start:2023-04-05
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05683457

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receipt of an allogeneic HCT.
  2. * CMV-seropositive, defined as a documented positive test for anti-CMV IgG.
  3. * High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCT from related or unrelated donor with myeloablative conditioning.
  4. * Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first study injection.
  5. * Persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.
  6. * Persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months after last study injection.
  7. * Persons who are not currently breast/chestfeeding.
  8. * Willingness to comply with study procedures and provide written informed consent.
  1. * History of a diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
  2. * A documented positive human immunodeficiency virus (HIV) test.
  3. * Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent in-vivo T cell depleting agent within 12 months.
  4. * HCT with ex-vivo T cell depletion.
  5. * Low risk for CMV: HCT from related or unrelated donor with reduced intensity conditioning (RIC) and no other high-risk features.
  6. * History of prior hematopoietic cell transplantation within 12 months.
  7. * 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.
  8. * Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.

Contacts and Locations

Study Contact

Moderna Clinical Trials Support Center
CONTACT
1-877-777-7187
clinicaltrials@modernatx.com

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2023-04-05
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • Human cytomegalovirus
  • Human Herpesvirus
  • mRNA-1647
  • Moderna
  • CMV
  • Cytomegalovirus Vaccine
  • Cytomegalovirus Infections
  • Cytomegalovirus Congenital
  • Virus Disease
  • Infection Viral
  • DNA Virus Infections
  • Messenger RNA
  • Hematopoietic cell transplantation

Additional Relevant MeSH Terms

  • Cytomegalovirus Infection