RecruitingPhase 1NCT07020533

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

A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant


Sponsor

City of Hope Medical Center

Enrollment

46 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, Electronic Health Record Review, and others for people with accelerated phase chronic myeloid leukemia, bcr-abl1 positive, acute lymphoblastic leukemia, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERElectronic Health Record Review

Ancillary studies

PROCEDUREHaploidentical Hematopoietic Cell Transplantation

Undergo HCT

DRUGLetermovir

Given IV or PO

BIOLOGICALMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDUREMyeloablative Conditioning

Receive myeloablative conditioning

PROCEDUREPheresis

Undergo apheresis

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given G-CSF


Locations(3)

City of Hope Medical Center

Duarte, California, United States

Northside Hospital

Atlanta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07020533


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