RecruitingPhase 2NCT06059391

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

Placebo-Controlled and Randomized Phase 2 Trial of CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients After Hematopoietic Stem Cell Transplant

Sponsor

City of Hope Medical Center

Enrollment

216 participants

Start Date

Jul 12, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Lymphocytic Leukemia Hodgkin Lymphoma Non-Hodgkin Lymphoma Hematopoietic and Lymphoid System Neoplasm Myelodysplastic Syndrome Myelofibrosis Myeloproliferative Neoplasm Chronic Myeloid Leukemia, BCR-ABL1 Positive

Summary

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vaccinating stem cell donors against CMV (cytomegalovirus) before they donate can protect the transplant recipient from developing a CMV infection after their stem cell transplant. **You may be eligible if...** - You are a donor: 18 years or older and consenting to the study - You are a recipient: willing to comply with the study procedures and about to receive a stem cell transplant from a matched related donor **You may NOT be eligible if...** - You are unable or unwilling to provide informed consent - You have conditions that make the vaccine or transplant unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo HCT with donor peripheral blood stem cells

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGGranulocyte Colony-Stimulating Factor

Undergo stem cell mobilization with G-CSF

DRUGHematopoietic Cell Transplantation Conditioning Regimen

Receive pre transplant conditioning

BIOLOGICALMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDUREPheresis

Undergo apheresis

DRUGPlacebo Administration

Given IM

DRUGStem Cell Mobilization Therapy

Undergo stem cell mobilization with G-CSF

Locations(3)

City of Hope Medical Center

Duarte, California, United States

Northside Hospital

Atlanta, Georgia, United States

DFCI/BWH Brigham and Women's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06059391

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