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

Summary

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.

Conditions

• Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Hematopoietic and Lymphatic System Neoplasm
• Hodgkin Lymphoma
• Lymphoblastic Lymphoma
• Myelodysplastic Syndrome
• Myelofibrosis
• Myeloproliferative Neoplasm
• Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Haploidentical Hematopoietic Cell Transplantation

Undergo HCT

DRUG

Letermovir

Given IV or PO

BIOLOGICAL

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDURE

Myeloablative Conditioning

Receive myeloablative conditioning

PROCEDURE

Pheresis

Undergo apheresis

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given G-CSF

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Ryotaro Nakamura · City of Hope Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-08

Primary Completion

2030-02-14

Completion

2030-02-14

FDA Drug

Yes

Countries

• United States

Study Locations