OncRef

Clinical Trial: NCT02506933

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:City of Hope Medical Center
Information Provided By:City of Hope Medical Center
Last Update Posted:2026-07-28

Study Overview

Brief Summary

This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.

Official Title

A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant

Conditions

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, Cytomegaloviral Infection, Hodgkin Lymphoma, Lymphadenopathy, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma

Intervention / Treatment

  • Other: Laboratory Biomarker Analysis
  • Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
  • Other: Placebo

Other Study ID Numbers

  • 14295
  • NCI-2015-01228
  • 14295
  • R01CA077544

Start Date (Actual)

2015-12-21

Primary Completion Date (Actual)

2018-01-25

Study Completion Date (Estimated)

2027-05-10

Enrollment (Actual)

102

Study Type

Interventional

Phase

Phase 2