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
Eligible age
18–75 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ 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 be confirmed as negative, a serum pregnancy test will be required.
- ✓ DONORS: Agreement by females and males of childbearing potential\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.
- ✓ Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
You may not qualify if…
- ✕ DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).
- ✕ DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.
- ✕ DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.
- ✕ DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.
- ✕ DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.
- ✕ DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.
- ✕ DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.
- ✕ DONORS: Females only: Pregnant or breastfeeding.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07020533 · last updated 2026-03-27