A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant
City of Hope Medical Center
Summary
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.
Description
PRIMARY OBJECTIVE: I. To evaluate whether the multi-peptide cytomegalovirus-modified vaccinia Ankara vaccine (CMV-MVA Triplex \[Triplex\]) vaccination of stem cell donors (D) and recipients (R) alone or in combination with letermovir safely protects against CMV events for day (d)100 in the absence of preemptive therapy (PET) and to determine the recommended duration of letermovir use as phase 2 modality in the haploidentical stem cell transplantation (haploHCT)-R. SECONDARY OBJECTIVES: I. To evaluate safety of Triplex in the haploHCT-R. II. To evaluate cumulative incidence of CMV events up…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely. * Remote consent, when appropriate, will be obtained per institutional guidelines. * Assent, when appropriate, will be obtained per institutional guidelines. * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol. * DONORS: Age: 18 - 75. * DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureHaploidentical Hematopoietic Cell Transplantation
Undergo HCT
- DrugLetermovir
Given IV or PO
- BiologicalMulti-peptide CMV-Modified Vaccinia Ankara Vaccine
Given IM
- ProcedureMyeloablative Conditioning
Receive myeloablative conditioning
- ProcedurePheresis
Locations (3)
- City of Hope Medical CenterDuarte, California
- Northside HospitalAtlanta, Georgia
- Dana-Farber Cancer InstituteBoston, Massachusetts