Phase
Condition
Cytomegalovirus Infections
Treatment
mRNA-1647
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 withpost-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis;or HCT from related or unrelated donor with at least one mismatch at any of thefollowing human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCTfrom related or unrelated donor with myeloablative conditioning.
Persons of nonchildbearing potential or of childbearing potential with negativeurine or serum pregnancy test on the day of first study injection.
Persons of childbearing potential who have practiced adequate contraception or haveabstained from all activities that could result in pregnancy for at least 28 daysprior to the first dose.
Persons of childbearing potential who have agreed to continue adequate contraceptionor abstain from all activities that could result in pregnancy through 3 months afterlast study injection.
Persons who are not currently breast/chestfeeding.
Willingness to comply with study procedures and provide written informed consent.
Exclusion
Exclusion Criteria:
History of a diagnosis or condition that, in the judgment of the Investigator, mayaffect participant safety, assessment of safety endpoints, assessment of immuneresponse, or adherence to study procedures.
A documented positive human immunodeficiency virus (HIV) test.
Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or anyequivalent 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 intensityconditioning (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 CMVtherapeutic study that may interfere with study outcome measures as determined bythe Investigator.
Suspected or known allergic reaction to any component of any mRNA vaccine or itsexcipients.
Study Design
Connect with a study center
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
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