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

NCT05683457 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: mRNA-1647-P205
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cytomegalovirus Infection

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy

  Day 100 to Month 9

• Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

  Up to Day 187 (7 days after last study injection)

• Number of Unsolicited Adverse Events (AEs)

  Up to Day 205 (25 days after last study injection)

• Number of Participants with Severe AEs

  Up to Day 365

• Number of Participants with Serious Adverse Events (SAEs)

  Up to Day 365

• Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)

  Up to Day 365

Secondary Outcomes (10)

• Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease

  Day 100 to Month 9

• Number of Participants with an Occurrence of CMV Viremia

  Day 100 to Month 9

• Number of Participants with CMV End-Organ Disease

  Day 100 to Month 9

• Duration of CMV Viremia

  Day 100 to Month 9

• Duration of CMV Treatment

  Day 100 to Month 9

Study Arms (2)

mRNA-1647

EXPERIMENTAL

Participants will receive mRNA-1647 by intramuscular (IM) injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.

Biological: mRNA-1647

Placebo

PLACEBO COMPARATOR

Participants will receive mRNA-1647 matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.

Biological: Placebo

Interventions

mRNA-1647 BIOLOGICAL

Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline).

mRNA-1647

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

Eligibility Criteria

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

You may qualify if:

• 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 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.
• Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first study injection.
• 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.
• 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.
• Persons who are not currently breast/chestfeeding.
• Willingness to comply with study procedures and provide written informed consent.

You may not qualify if:

• 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.
• A documented positive human immunodeficiency virus (HIV) test.
• Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent 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 intensity conditioning (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 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 or its excipients.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

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

Central Study Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762; WeCareClinicalTrials@modernatx.com

Study Design

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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (3)