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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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 10 versions: 10 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Jan 1, 2028 to Jan 1, 2027 Show 5 more changesShow less
    • Study completion moved earlier from Jan 1, 2029 to Jan 1, 2028
    • Start date: Jul 12, 2024 to Jul 9, 2024
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: details revised at 5 of 13 entries
    • Site details revised at 1 of 3 sites
  2. Secondary endpoints: details revised at 5 of 13 entriesv9
  3. Primary completion date: Jan 1, 2027 to Jan 1, 2028
    • Study completion date: Jan 1, 2028 to Jan 1, 2029
    • Site contacts updated at 3 of 3 sites
    v8
  4. Study sites: 2 to 3v7
  5. Start date changed from estimate of Aug 30, 2024 to Jul 12, 2024
    • Site contacts updated at 2 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Apr 30, 2024 to Aug 30, 2024v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Aug 14, 2025 to Jan 1, 2027
    • Study completion date: Aug 14, 2025 to Jan 1, 2028
    • Start date: Apr 25, 2024 to Apr 30, 2024
    • Site details revised at 2 of 2 sites
  3. Start date: Dec 25, 2023 to Apr 25, 2024v3
  4. Start date: Oct 25, 2023 to Dec 25, 2023v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Time from transplantation to cytomegalovirus (CMV) disease or pre-emptive treatment following CMV reactivation (efficacy)
Timeframe: From hematopoietic stem cell transplantation (HCT) to day 180
Occurrence of non-relapse mortality (safety in HCT-recipients)
Timeframe: Up to day 100 post HCT
Incidence of severe acute graft versus host disease (aGHVD) (safety in HCT-recipients)
Timeframe: Up to 100 days post HCT
Incidence of severe adverse events (AEs) (safety in HCT-recipients)
Timeframe: Within 2 weeks from transplantation and up to 1 year post HCT
Incidence of grade 3 and higher AEs (safety in HCT-donors)
Timeframe: Within 14 days

Secondary (13)

Time-to viremia (CMV-related events)
Duration of viremia (CMV-related events)
Incidence of late CMV viremia (CMV-related events)
Use of antiviral drugs (CMV-related events)
Cumulative number of CMV specific antiviral treatment days (CMV-related events)
Show 8 moreShow less
Incidence of CMV disease (CMV-related events)
Time to engraftment (transplant-related events)
Incidence of aGVHD and chronic GVHD (transplant-related events)
Incidence of relapse (transplant-related events)
Non-relapse mortality (transplant-related events)
All-cause mortality (transplant-related events)
Incidence of infections (transplant-related events)
Levels and kinetics of CMV-specific T cell immunity, combined with immunophenotyping, and functional studies (immunological function)

Arms and interventions

Arm I (Triplex vaccination)Experimental

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.

Arm II (Placebo)Placebo comparator

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.

Procedures: Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Pheresis

Drugs: Granulocyte Colony-Stimulating Factor, Hematopoietic Cell Transplantation Conditioning Regimen, Placebo Administration, Stem Cell Mobilization Therapy

Biologicals: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

Sites

3 sites in 1 country