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NCT00285259 Clinical Trial

Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285259
Other study ID # CB01-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 31, 2006
Est. completion date November 30, 2010

Study information
Verified date September 2023
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

This study was run by Vical and the record was transferred to Astellas on 1/8/2013. Trial will enroll up to 240 subjects (160 recipients and 80 donors). Qualified donors and/or CMV-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be assigned randomly to receive either a CMV vaccine or a placebo vaccine. Donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant. Recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the CMV vaccine. The incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation will be studied.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date November 30, 2010
Est. primary completion date November 30, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - males and females age 18-65 - 5/6 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 Exclusion Criteria: - planned prophylactic cytomegalovirus antiviral therapy - planned immunosuppression with alemtuzumab (CAMPATH-IH) - planned prophylactic therapy with CMV immunoglobulin - autoimmune disease

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• VCL-CB01
5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
Other:
• Phosphate-buffered Saline (PBS)
1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States Brigham and Women's Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Roswell Park Cancer Institute Corporation Buffalo New York
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Chicago Illinois
United States Baylor University Medical Center Dallas Texas
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Rocky Mountain Cancer Center Denver Colorado
United States Karmanos Cancer Institute Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Hackensack University Medical Center # 408 Hackensack New Jersey
United States James Graham Brown Cancer Center Louisville Kentucky
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic Rochester Minnesota
United States Strong Memorial Hospital Rochester New York
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States University of South Florida Tampa Florida
United States Arizona Cancer Center Tucson Arizona
United States University of Kansas Medical Center Westwood Kansas
United States North Carolina Baptist Hosptial Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Vical

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: Lancet Infect Dis. 2012 Apr;12(4):266. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT 1 year
Primary occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine. 1 year
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