New mRNA vaccine aims to shield transplant patients from dangerous virus
NCT ID NCT05683457
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study tests an mRNA vaccine (mRNA-1647) to prevent cytomegalovirus (CMV) infection in people who have had a stem cell transplant. About 84 participants will receive either the vaccine or a placebo. The goal is to see if the vaccine can safely prevent CMV after stopping standard preventive drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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84 people
The number who actually took part.
- Started
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Apr 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can cord blood t cells be trained to stop viral infections after transplant?
- Can a new IV antiviral tame two stubborn viruses?
- A new drug combo may shield kidney transplant patients from a common viral threat
- Blood test could tailor CMV prevention after stem cell transplants
- Can 'Supercharged' donor cells beat viruses that drugs Can't?
- Banked immune cells show promise against Life-Threatening viruses in transplant patients