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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCity of Hope Medical Center

About this trial

This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.

Eligibility criteria

Qualifiers

DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.

Remote consent, when appropriate, will be obtained per institutional guidelines.

Assent, when appropriate, will be obtained per institutional guidelines.

Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.

Disqualifiers

DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).

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 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

  • Biospecimen Collection
  • Electronic Health Record Review
  • Haploidentical Hematopoietic Cell Transplantation
  • Letermovir
  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
  • Myeloablative Conditioning
  • Pheresis
  • Recombinant Granulocyte Colony-Stimulating Factor

Treatment groups

46 Participants
are divided into 4 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator