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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07020533
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Haploidentical Hematopoietic Cell Transplantation — PROCEDURE
    Undergo HCT
  • Letermovir — DRUG
    Given IV or PO
  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — BIOLOGICAL
    Given IM
  • Myeloablative Conditioning — PROCEDURE
    Receive myeloablative conditioning
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Recombinant Granulocyte Colony-Stimulating Factor — BIOLOGICAL
    Given G-CSF

Study Details

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.

Key Dates

Start date
May 8, 2026
Status verified
Mar 2026
Primary completion
Feb 14, 2030
Completion
Feb 14, 2030

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Donors (CMV-MVA Triplex vaccine, G-CSF)
    Participants receive CMV-MVA Triplex vaccine IM once and then receive G-CSF on study. Additionally, participants undergo apheresis on study as well as blood sample collection on study and may optionally undergo blood sample collection during follow up.
  • Experimental: Recipients, Modality 1 (CMV-MVA Triplex vaccine, letermovir)
    Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100 and receive letermovir IV over 1 hour or PO QD on days 7 to 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
  • Experimental: Recipients, Modality 2 (CMV-MVA Triplex vaccine, letermovir)
    Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100 and receive letermovir IV over 1 hour or PO QD on days 7 to 28. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
  • Experimental: Recipients, Modality 3 (CMV-MVA Triplex vaccine)
    Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Cytomegalovirus (CMV) reactivation prompting antiviral therapy [ Time Frame: From day 0 to day 100 post-hematopoietic stem cell transplant (HCT) ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Ryotaro Nakamura
[email protected]
626-256-4673
Ryotaro Nakamura (PRINCIPAL_INVESTIGATOR)
Northside HospitalAtlantaGeorgia30342
Scott R. Solomon
[email protected]
404-255-1930
Scott R. Solomon (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Lindsey R. Baden
[email protected]
617-732-6801
Lindsey R. Baden (PRINCIPAL_INVESTIGATOR)

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