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NCT07020533

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

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 8 months later.

See at-risk trials from City of Hope Medical Center

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Feb 14, 2030 Show 5 more changesShow less
    • Start date: May 8, 2026 to Sep 9, 2026
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: details revised at 14 of 15 entries
    • Study description revised
    • Site details revised at 1 of 3 sites
  2. Study sites revised (3)v7
  3. Study completion pushed from May 30, 2028 to May 30, 2029
    • Start date: Jun 30, 2026 to May 8, 2026
    v6
  4. Primary and study completion moved earlier from Feb 14, 2030 to May 30, 2028v5
  5. Primary and study completion dates: Feb 14, 2030 to May 30, 2028
    • Start date changed from estimate of Aug 30, 2026 to Jun 30, 2026
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 8, 2026 to Aug 30, 2026v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 1, 2027 to Feb 14, 2030
    • Site details revised at 3 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Cytomegalovirus (CMV) reactivation prompting antiviral therapy
Timeframe: From day 0 to day 100 post-hematopoietic stem cell transplant (HCT)
CMV disease
Timeframe: From day 0 to day 100 post-HCT

Secondary (15)

Unacceptable toxicity
Serious adverse events (SAE)
Incidence of acute graft-versus-host disease (GVHD)
Non-relapse mortality (NRM)
CMV events
Show 10 moreShow less
CMV viremia
Incidence of late CMV viremia
Neutrophil engraftment
Platelet engraftment
Incidence of severe acute GVHD
Incidence of severe chronic GVHD
NRM
Relapse
Overall survival (OS)
CMV-specific T cell immunity

Arms and interventions

Donors (CMV-MVA Triplex vaccine, G-CSF)Experimental

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.

Recipients, Modality 1 (CMV-MVA Triplex vaccine, letermovir)Experimental

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.

Recipients, Modality 2 (CMV-MVA Triplex vaccine, letermovir)Experimental

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.

Recipients, Modality 3 (CMV-MVA Triplex vaccine)Experimental

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.

Procedures: Biospecimen Collection, Haploidentical Hematopoietic Cell Transplantation, Myeloablative Conditioning, Pheresis

Other: Electronic Health Record Review

Drugs: Letermovir

Biologicals: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine, Recombinant Granulocyte Colony-Stimulating Factor

Sites

3 sites in 1 country