Actively Recruiting
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-27
46
Participants Needed
3
Research Sites
196 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donors must provide documented informed consent.
- Donors aged 18 to 75 years.
- Donor women of childbearing potential must have a negative pregnancy test.
- Donors of childbearing potential must agree to use effective birth control or abstain from heterosexual activity before and up to 90 days post-vaccination.
- Recipients must provide documented informed consent or have a legally authorized representative provide consent.
- Recipients must be willing to comply with study and follow-up procedures for one year post-transplant.
- Recipients aged 18 to 75 years.
- Recipients planned for peripheral blood stem cell or bone marrow transplant for specific hematologic cancers including lymphoma, myelodysplastic syndrome, acute lymphoblastic leukemia (in remission), acute myeloid leukemia (in remission), chronic myelogenous leukemia (in certain phases), chronic lymphocytic leukemia, myeloproliferative disorders, and myelofibrosis.
- Recipients may receive myeloablative or reduced intensity conditioning.
- Recipients must be CMV seropositive.
- Recipients must have a haploidentical donor with specified HLA mismatches and at least one identical allele.
- Recipients planned for transplant with minimal to no T-cell depletion.
- Recipients must meet institutional guidelines for liver and kidney function tests and cardiac and lung function.
- Recipients must be seronegative for HIV, active hepatitis B, hepatitis C, and syphilis or have undetectable viral loads if positive.
- Female recipients of childbearing potential must have a negative pregnancy test.
- Recipients of childbearing potential must agree to use effective birth control or abstain from heterosexual activity before and up to 90 days post-transplant.
You will not qualify if you...
- Donors with any prior transplant before day 1 of protocol therapy.
- Donors who had chemotherapy, radiation, biological therapy, or immunotherapy within 21 days prior to day 1 of protocol therapy.
- Donors who received any vaccine within 30 days before or after the study vaccine.
- Donors unfit for stem cell mobilization or apheresis, including abnormal blood counts or history of stroke.
- Donors with sickling hemoglobinopathies (e.g., HbSS, HbAS, HbSC).
- Donors with impaired cardiac function or severe psychiatric illness.
- Donor females who are pregnant or breastfeeding.
- Donors unable to comply with study procedures.
- Recipients who had prior investigational CMV vaccine.
- Recipients who received experimental anti-CMV chemotherapy in the last 6 months.
- Recipients planned to receive live attenuated, subunit, killed vaccines, allergy antigen injections, or certain T-cell depleting agents from transplant to day 70 post-transplant.
- Recipients using antiviral medications effective against CMV (except letermovir prophylaxis) from transplant to day 70 post-transplant.
- Recipients with active autoimmune conditions needing systemic immunosuppressive therapy within 5 years.
- Recipients with complicated prior therapy or low survival probability.
- Recipients with poor risk disease status (e.g., CML blast crisis, AML/ALL beyond second remission, multiple myeloma, aplastic anemia).
- Recipient females who are pregnant or breastfeeding.
- Recipients unable to comply with study procedures or with safety concerns as judged by investigators.
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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