MedTrace Logo

A Cytomegalovirus-Directed Vaccine (CMV-alphaDC1) for Preventing Cytomegalovirus Infection or Reactivation in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

NCT05589844 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-27

No results posted yet for this study

Summary

This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic hematopoietic stem cell transplant. CMV is an opportunistic infection that can occur or reactivate after allogeneic hematopoietic stem cell transplant as a result of immunosuppression. The CMV-alphaDC1 vaccine is made of white blood cells that have been exposed to molecules called cytokines, as well as CMV proteins. Introducing these dendritic cells to the patients immune system may activate an immune response to CMV, protecting against infection or reactivation.

Conditions

  • Cytomegaloviral Infection
  • Hematopoietic and Lymphoid System Neoplasm

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo standard of care allogeneic hematopoietic stem cell transplant

PROCEDURE

Biospecimen Collection

Correlative studies

BIOLOGICAL

CMV pp65 Peptide-loaded Alpha-type-1 Polarized Dendritic Cell Vaccine

Given intradermally

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • George L Chen · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-11-16
Completion
2025-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589844 on ClinicalTrials.gov