Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)
1 other identifier
interventional
112
1 country
22
Brief Summary
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2006
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2006
CompletedStudy Start
First participant enrolled
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2010
CompletedOctober 21, 2024
October 1, 2024
3.8 years
January 30, 2006
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT
1 year
occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
1 year
Study Arms (2)
VCL-CB01
EXPERIMENTALPlacebo
PLACEBO COMPARATORPBS
Interventions
5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
Eligibility Criteria
You may qualify if:
- males and females age 18-65
- /6 or 6/6 classic HLA allele-matched donor
- planned GCSF-mobilized peripheral blood stem cell transplant
- CMV-seropositive recipient
- planned transplant with minimal or no T-cell depletion
- Acute Lymphoblastic Leukemia (ALL) in first or second remission; Acute Myeloid Leukemia (AML) in first or second remission; Chronic Myelogenous Leukemia (CML) in first chronic or accelerated phase, or in second chronic phase; Hodgkin's and non-Hodgkin's lymphoma; myelodysplastic syndrome
You may not qualify if:
- planned prophylactic cytomegalovirus antiviral therapy
- planned immunosuppression with alemtuzumab (CAMPATH-IH)
- planned prophylactic therapy with CMV immunoglobulin
- autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Vicalcollaborator
Study Sites (22)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
University of South Florida
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center # 408
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute Corporation
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
North Carolina Baptist Hosptial
Winston-Salem, North Carolina, 27157, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Related Publications (1)
Kharfan-Dabaja MA, Boeckh M, Wilck MB, Langston AA, Chu AH, Wloch MK, Guterwill DF, Smith LR, Rolland AP, Kenney RT. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Apr;12(4):290-9. doi: 10.1016/S1473-3099(11)70344-9. Epub 2012 Jan 10.
PMID: 22237175BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard T. Kenney, MD
Vical
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2006
First Posted
February 1, 2006
Study Start
January 31, 2006
Primary Completion
November 30, 2009
Study Completion
November 30, 2010
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.