Actively Recruiting
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-10
216
Participants Needed
3
Research Sites
233 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 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.
CONDITIONS
Official Title
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donors must provide documented informed consent and be 18 years or older
- Recipients must provide documented informed consent and be 18 years or older
- Recipients must have a Karnofsky performance score of 70 or higher or ECOG score of 2 or less
- Recipients must have planned hematopoietic cell transplant for treatment of lymphoma (Hodgkin and Non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (first chronic or accelerated phase, or second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders, or myelofibrosis
- Recipients must be cytomegalovirus (CMV) seropositive
- Recipients must have planned related HCT with 8/8 high resolution HLA donor allele matching
- Recipients may receive myeloablative, reduced intensity, or nonmyeloablative conditioning per institutional guidelines
- Recipients must have total bilirubin less than or equal to 2 times upper limit of normal unless having Gilbert's disease
- Recipients must have AST and ALT less than or equal to 2.5 times upper limit of normal
- Recipients must have creatinine clearance of at least 60 mL/min by 24-hour urine test or Cockcroft-Gault formula
- Recipients must have left ventricular ejection fraction of at least 50% within 45 days before starting protocol therapy
- Recipients must have pulmonary function tests (FVC and DLCO) at least 50% of predicted or oxygen saturation over 92% on room air within 45 days before therapy
- Recipients must be negative for HIV antigen/antibody, hepatitis C virus, active hepatitis B virus, and syphilis, or have undetectable viral loads if positive
- Recipients must meet other institutional and federal infectious disease titer requirements within 45 days before therapy
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control or abstain from heterosexual activity prior to study and up to 90 days post-transplant
You will not qualify if you...
- Donors with prior transplant before day 1 of protocol therapy
- Donors who received chemotherapy, radiation, biological therapy, or immunotherapy within 21 days prior to day 1 of protocol therapy
- Donors who received any vaccine (licensed or investigational) within 30 days before or after the study vaccine
- Donors unfit for stem cell mobilization and apheresis due to abnormal blood counts, history of stroke, or uncontrolled hypertension
- Donors with sickling hemoglobinopathies such as HbSS, HbAS, or HbSC
- Donors with impaired cardiac function excluding minor ECG changes
- Donors positive for HIV, active hepatitis B, hepatitis C, or HTLV-I/II
- Donors with severe psychiatric illness or mental deficiency impairing consent or compliance
- Female donors who are pregnant or breastfeeding
- Donors with any condition judged unsafe for participation
- Donors unlikely to comply with study procedures
- Recipients with prior investigational CMV vaccine or experimental anti-CMV chemotherapy within 6 months
- Recipients with prior allogeneic transplant
- Recipients who received live attenuated vaccines or certain subunit/killed vaccines
- Recipients treated with alemtuzumab or equivalent T-cell depleting agents
- Recipients using antiviral medications effective against CMV except acyclovir
- Recipients receiving prophylactic CMV immunoglobulin or antiviral treatment
- Recipients enrolled in other investigational drug trials affecting CMV
- Recipients with autoimmune disease
- Female recipients who are pregnant or breastfeeding
- Recipients with any condition judged unsafe for participation
- Recipients unlikely to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
DFCI/BWH Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
V
Vaibhav Agrawal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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