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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06059391
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo HCT with donor peripheral blood stem cells
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Granulocyte Colony-Stimulating Factor — DRUG
    Undergo stem cell mobilization with G-CSF
  • Hematopoietic Cell Transplantation Conditioning Regimen — DRUG
    Receive pre transplant conditioning
  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — BIOLOGICAL
    Given IM
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Placebo Administration — DRUG
    Given IM
  • Stem Cell Mobilization Therapy — DRUG
    Undergo stem cell mobilization with G-CSF

Study Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Triplex vaccination)
    DONORS: Donors receive Triplex vaccine IM on day 0 and then undergo stem cell mobilization with G-CSF on days 5 to 9 and apheresis for peripheral blood stem cell collection on days 10 to 14 per standard of care. Donors may optionally undergo blood sample collection on study. RECIPIENTS: Recipients undergo pre-transplant conditioning on days -60 to 0 and undergo HCT with the donor peripheral blood stem cells within 9 weeks of donor vaccination on day 0. Recipients undergo blood sample collection on study.
  • Placebo Comparator: Arm II (Placebo)
    DONORS: Donors receive placebo IM on day 0 and undergo stem cell mobilization with G-CSF on days 5 to 9 and apheresis for peripheral blood stem cell collection on days 10 to 14 per standard of care. Donors may optionally undergo blood sample collection on study. RECIPIENTS: Recipients undergo pre-transplant conditioning on days -60 to 0 and undergo HCT with the donor peripheral blood stem cells within 9 weeks of donor vaccination on day 0. Recipients undergo blood sample collection on study.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Vaibhav Agrawal
[email protected]
626-256-4673
Vaibhav Agrawal (PRINCIPAL_INVESTIGATOR)
Northside HospitalAtlantaGeorgia30342
Scott R. Solomon, MD
[email protected]
404-255-1930
Scott R. Solomon (PRINCIPAL_INVESTIGATOR)
DFCI/BWH Brigham and Women's HospitalBostonMassachusetts02115
Lindsey Baden, MD
[email protected]
617-732-6801
Lindsey Baden, MD (PRINCIPAL_INVESTIGATOR)

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