Health Trials

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

ConditionsAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveHematopoietic and Lymphoid System NeoplasmHodgkin LymphomaMyelodysplastic SyndromeMyelofibrosisMyeloproliferative NeoplasmNon-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCity of Hope Medical Center

About this trial

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.

Eligibility criteria

Qualifiers

DONORS: Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

DONORS: Age: 18 and above

RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative

Disqualifiers

DONORS: Any prior transplant to day 1 of protocol therapy

DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy

DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after of the study vaccine

DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension

Trial design

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Biospecimen Collection
  • Granulocyte Colony-Stimulating Factor
  • Hematopoietic Cell Transplantation Conditioning Regimen
  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
  • Pheresis
  • Placebo Administration
  • Stem Cell Mobilization Therapy

Treatment groups

216 Participants
are divided into 2 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov