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CMV-MVA Triplex Vaccination for Stem Cell Donors

This study is testing if a vaccine called CMV-MVA Triplex given to stem cell donors can help prevent cytomegalovirus (CMV) infection in patients receiving a stem cell transplant. CMV is a common virus that can cause problems after a transplant. The vaccine works by creating immunity to CMV in the donor, which is then passed to the patient during the transplant. We are looking for people aged 18 to 75 with certain blood cancers like Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia who are receiving a stem cell transplant from a matched related donor. The main goal is to see if the vaccine reduces CMV infections or the need for treatment for CMV, and to check for serious side effects like non-relapse mortality or severe acute graft versus host disease. The current recruitment status is unclear.

Study design
This is a Phase 2 interventional study with 216 planned participants. Donors will be randomly assigned to receive either the CMV-MVA Triplex vaccine or a placebo.
What's involved
Donors will receive an injection, undergo stem cell mobilization with G-CSF, and have blood collected. Recipients will undergo pre-transplant conditioning and blood sample collection.
Compensation
Not stated in the trial record.
Follow-up
Patients will be followed for CMV disease or treatment up to 180 days after transplant, and for non-relapse mortality and severe acute graft versus host disease up to 100 days post-transplant.

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NCT06059391

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

Recruiting
PHASE2Ages 18–75InterventionalTreatment
City of Hope Medical Center
~216 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationBiospecimen CollectionGranulocyte Colony-Stimulating FactorHematopoietic Cell Transplantation Conditioning RegimenMulti-peptide CMV-Modified Vaccinia Ankara VaccinePheresis

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from transplantation to cytomegalovirus (CMV) disease or pre-emptive treatment following CMV reactivation (efficacy)
Measured over From hematopoietic stem cell transplantation (HCT) to day 180
+4 more outcomes measured

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia, BCR-ABL1 Positive
Hematopoietic and Lymphoid System Neoplasm
Hodgkin Lymphoma
Myelodysplastic Syndrome
Myelofibrosis
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveHodgkin's GranulomaMyelodysplastic SyndromeMyelofibrosisMyeloproliferative NeoplasmNon-Hodgkin LymphomaCytomegaloviral InfectionHLA Complex

Where it's being run

3 sites across 3 states
California1
Georgia1
Massachusetts1

Study leadership

  • Vaibhav Agrawal, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Vaibhav Agrawal, MD
[email protected]
626-359-8111
Email the study team

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Eligibility criteria

Inclusion

DONORS: Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
DONORS: Age: 18 and above
RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
RECIPIENTS: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
RECIPIENTS: Age: 18 and above
RECIPIENTS: Karnofsky performance score ≥ 70 or ECOG ≤ 2
RECIPIENTS: 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, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma are excluded
RECIPIENTS: CMV seropositive
RECIPIENTS: Planned related HCT with 8/8 (A, B, C, DRB1) high resolution human leukocyte antigen (HLA) donor allele matching
RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted. Patients may receive myeloablative, reduced intensity, or nonmyeloablative conditioning
RECIPIENTS: Total bilirubin ≤ 2 X upper limit of normal (ULN) (unless has Gilbert's disease)
RECIPIENTS: Aspartate aminotransferase (AST) ≤ 2.5 x ULN
RECIPIENTS: Alanine aminotransferase (ALT) ≤ 2.5 x ULN
RECIPIENTS: Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50% Note: To be performed within 45 days prior to day 1 of protocol therapy
RECIPIENTS: If able to perform pulmonary function tests: forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin). If unable to perform pulmonary function tests: oxygen (O2) saturation \> 92% on room air Note: To be performed within 45 days prior to day 1 of protocol therapy
RECIPIENTS: Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV)\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])
If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements Note: Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy
RECIPIENTS: 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
RECIPIENTS: 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-HCT.
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

DONORS: Any prior transplant to day 1 of protocol therapy
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 of 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 S (HbSS), sickle cell trait (HbAS), hemoglobin sickle C disease (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: Positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II)
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
DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
DONORS: 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)
RECIPIENTS: Any prior investigational CMV vaccine
RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months
RECIPIENTS: Prior allogeneic (allo) transplant for any condition
RECIPIENTS: Live attenuated vaccines
RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
RECIPIENTS: Allergy treatment with antigens injections
RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent
RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as valganciclovir/ganciclovir (GCV/VAL), foscarnet (FOS), cidofovir, brincidofovir (CMX-001), maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)
RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment
RECIPIENTS: 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
RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product
RECIPIENTS: Diagnosis with autoimmune disease
RECIPIENTS: Females only: Pregnant women and women who are lactating. The risks of Triplex to pregnant women are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother. Breastfeeding should be discontinued if the mother is enrolled on this study
RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
RECIPIENTS: 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)

What this trial measures

  • Time from transplantation to cytomegalovirus (CMV) disease or pre-emptive treatment following CMV reactivation (efficacy)From hematopoietic stem cell transplantation (HCT) to day 180

    A stratified Cox regression analysis of time to CMV disease or positron emission tomography (PET) following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.

  • Occurrence of non-relapse mortality (safety in HCT-recipients)Up to day 100 post HCT

    A stratified Cox regression analysis of time to CMV disease or PET following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.

  • Incidence of severe acute graft versus host disease (aGHVD) (safety in HCT-recipients)Up to 100 days post HCT

    Severe aGHVD defined as grades 3-4. A stratified Cox regression analysis of time to CMV disease or PET following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.

  • Incidence of severe adverse events (AEs) (safety in HCT-recipients)Within 2 weeks from transplantation and up to 1 year post HCT

    Probably or definitely related to the vaccination per Common Terminology Criteria for Adverse Events version 5.0. A stratified Cox regression analysis of time to CMV disease or PET following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.

  • Incidence of grade 3 and higher AEs (safety in HCT-donors)Within 14 days

    A stratified Cox regression analysis of time to CMV disease or PET following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.