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
City of Hope Medical Center
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.
Description
PRIMARY OBJECTIVE: I. To determine whether multi-peptide CMV-modified vaccinia Ankara vaccine (Triplex) is safe and effective in protecting against CMV events defined as viremia requiring antiviral preemptive therapy (PET) or CMV end organ disease. SECONDARY OBJECTIVE: I. To examine if Triplex vaccination of hematopoietic stem cell transplant (HCT) donors has an impact on CMV events. OUTLINE: Donors are randomized to 1 of 2 arms. ARM I: DONORS: Donors receive Triplex vaccine intramuscularly (IM) on day 0 and then undergo stem cell mobilization with granulocyte colony-stimulating factor (…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * DONORS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * DONORS: Age: 18 and above * RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * RECIPIENTS: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * RECIPIENTS: Age: 18 and above * RECIPIENTS:…
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
Locations (3)
- City of Hope Medical CenterDuarte, California
- Northside HospitalAtlanta, Georgia
- DFCI/BWH Brigham and Women's HospitalBoston, Massachusetts