Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT02506933
Run by: City of Hope Medical Center
People needed: 102
Starts: 2015-12-21
Expected to finish: 2027-05-10
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All subjects must have the ability to understand and the willingness to sign a written informed consent
Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
Planned HCT for the treatment of the following hematologic malignancies:
Lymphoma (Hodgkin and Non-Hodgkin)
Myelodysplastic syndrome
Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography (PET) scan without progression is allowed)
Acute myeloid leukemia in first or second remission
Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded
Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
CMV seropositive (recipient)
Planned related or unrelated HCT, with 8/8 (A,B,C,DRB1) high/intermediate resolution HLA donor allele matching
Planned HCT with minimal to no-T cell depletion of graft
Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration
Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

You may not qualify if…

Any prior investigational CMV vaccine
Experimental anti-CMV chemotherapy in the last 6 months
Live attenuated vaccines
Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
Allergy treatment with antigens injections
Alemtuzumab or any equivalent in vivo T-cell depleting agent
Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valganciclovir (VAL), foscarnet (FOS), Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment
Other investigational product - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

City of Hope Medical Center — Duarte, California, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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