Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
NCT02506933 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2026-05-11
Summary
This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.
Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Chronic Lymphocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Cytomegaloviral Infection
- Hodgkin Lymphoma
- Lymphadenopathy
- Lymphoblastic Lymphoma
- Myelodysplastic Syndrome
- Myelofibrosis
- Myeloproliferative Neoplasm
- Non-Hodgkin Lymphoma
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Given IM
- OTHER
-
Placebo
Given IM
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Diavax Biosciences
collaborator INDUSTRY -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Ryotaro Nakamura, MD · City of Hope Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-21
- Primary Completion
- 2018-01-25
- Completion
- 2026-06-09
Countries
- United States
Study Locations
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