CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Blood Cancer Undergoing Donor Stem Cell Transplant

  • STATUS
    Not Recruiting
  • End date
    Mar 18, 2023
  • participants needed
    36
  • sponsor
    City of Hope Medical Center
Updated on 20 October 2022
cancer
remission
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
hematologic malignancy
cytomegalovirus infection
chronic lymphocytic leukemia
vaccinia
immunodeficiency
lymphoma
myelofibrosis
multiple myeloma
hodgkin's disease
myeloproliferative disorder
immunosuppressive
beta-human chorionic gonadotropin
modified vaccinia ankara
immunosuppressive agents
hepatitis
leukemia
lymphocytic leukemia
human chorionic gonadotropin
beta human chorionic gonadotropin
beta human chorionic gonadotrophin
multi-peptide cmv-modified vaccinia ankara vaccine
myelogenous leukemia
myeloproliferative disorders
Accepts healthy volunteers

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.

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.

Details
Condition Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, 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
Treatment Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Clinical Study IdentifierNCT03560752
SponsorCity of Hope Medical Center
Last Modified on20 October 2022

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