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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.
Conditions: Cytomegalovirus Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 84
Sponsor: ModernaTX, Inc.
Location: Dana-Farber Cancer Institute Boston Massachusetts
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05683457). StuddyBuddy aggregates publicly available trial information.