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

Launched by MODERNATX, INC. · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying an experimental vaccine called mRNA-1647, which is designed to prevent cytomegalovirus (CMV) infections in people who have recently received a stem cell transplant. The goal is to see how effective and safe this vaccine is compared to a placebo (a harmless substance with no active medication) in preventing significant CMV infections during the first nine months after the transplant, particularly after stopping preventive treatments.

To participate in the trial, individuals must have received a type of transplant called allogeneic hematopoietic cell transplantation (HCT) and be at high risk for CMV. They must also have a positive test for CMV antibodies and meet certain criteria related to pregnancy and contraception. Participants will receive either the vaccine or the placebo and will be monitored throughout the study to assess safety and effectiveness. This trial is currently recruiting people aged 18 and older, regardless of gender. If you or someone you know is interested in this study, it’s important to talk to a healthcare provider for more information.

Gender

ALL

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.