Trials / Active Not Recruiting
Active Not RecruitingNCT03560752
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant
CMV-MVA Triplex Vaccination of Stem Cell Donors to Enhance CMV Specific Immunity and Prevent CMV Viremia in Recipients After Stem Cell Transplant
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This phase II trial studies how well multi-peptide CMV-modified vaccinia Ankara (CMV-MVA Triplex) vaccination of stem cell donors works in preventing cytomegalovirus (CMV) viremia in participants with blood cancer undergoing donor stem cell transplant. Giving a vaccine to the donors may boost the recipient's immunity to this virus and reduce the chance of CMV disease after transplant.
Detailed description
PRIMARY OBJECTIVES: I. Establish the feasibility and safety of priming CMV immunity in donors by Triplex vaccination prior to peripheral blood stem cell (PBSC) harvest. SECONDARY OBJECTIVES: I. Examine if Triplex vaccination of hematopoietic stem cell transplant (HCT) donors has an impact on CMV events. OUTLINE: Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization. Participants undergo hematopoietic cell transplantation on day 0. After completion of study treatment, participants are followed up for 1 year.
Conditions
- Accelerated Phase CML, BCR-ABL1 Positive
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Chronic Lymphocytic Leukemia
- Chronic Phase CML, BCR-ABL1 Positive
- Cytomegalovirus Positive
- Donor
- Hematopoietic Cell Transplant Recipient
- Hodgkin Lymphoma
- Myelodysplastic Syndrome
- Myelodysplastic/Myeloproliferative Neoplasm
- Non-Hodgkin Lymphoma
- Myelofibrosis
- Hematopoietic and Lymphoid Cell Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Multi-peptide CMV-Modified Vaccinia Ankara Vaccine | Given via injection |
Timeline
- Start date
- 2018-08-20
- Primary completion
- 2022-01-22
- Completion
- 2026-07-29
- First posted
- 2018-06-18
- Last updated
- 2025-12-10
- Results posted
- 2024-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03560752. Inclusion in this directory is not an endorsement.