Actively Recruiting
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
Led by ModernaTX, Inc. · Updated on 2026-03-16
224
Participants Needed
3
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 GVHD prophylaxis; or HCT from related or unrelated donor with at least one mismatch at HLA-A, B, C, or DRB1; or HCT from related or unrelated donor with myeloablative conditioning.
- Persons of nonchildbearing potential or of childbearing potential with negative pregnancy test on the day of first study injection.
- Persons of childbearing potential who have practiced adequate contraception or abstained from pregnancy-risk activities for at least 28 days prior to first dose.
- Persons of childbearing potential who agree to continue contraception or abstain from pregnancy-risk activities through 3 months after last study injection.
- Persons not currently breast/chestfeeding.
- Willingness to comply with study procedures and provide written informed consent.
You will not qualify if you...
- History of diagnosis or condition that may affect safety, immune response, or adherence as judged by Investigator.
- Documented positive HIV test.
- Treatment with alemtuzumab, antithymocyte globulin, or equivalent T cell depleting agents within 12 months.
- HCT with ex-vivo T cell depletion.
- Low risk for CMV: HCT from related or unrelated donor with reduced intensity conditioning and no other high-risk features.
- History of prior hematopoietic cell transplantation within 12 months.
- Receipt of prior investigational CMV vaccines or participation in other CMV therapeutic studies that may interfere with outcomes.
- Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Moderna WeCare Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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