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NCT05683457

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalPrevention
ModernaTX, Inc.
~84 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:mRNA-1647Placebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy
Measured over Day 100 to Month 9
+5 more outcomes measured

Conditions

Cytomegalovirus Infection

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Cytomegaloviral Infection

NCT05683457

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

  • Fred Hutchinson Cancer Center

    Seattle, Washingtonno site contact published

  • Washington University School of Medicine

    St Louis, Missourino site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

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