Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
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ClinicalTrials.gov Identifier: NCT00285259 |
Recruitment Status :
Completed
First Posted : February 1, 2006
Last Update Posted : August 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Myelodysplastic Syndrome | Biological: VCL-CB01 Other: Phosphate-buffered Saline (PBS) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: VCL-CB01 |
Biological: VCL-CB01
5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients |
Placebo Comparator: Placebo
PBS
|
Other: Phosphate-buffered Saline (PBS)
1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients |
- Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT [ Time Frame: 1 year ]
- occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285259

Study Chair: | Richard T. Kenney, MD | Vical |
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00285259 |
Other Study ID Numbers: |
CB01-202 |
First Posted: | February 1, 2006 Key Record Dates |
Last Update Posted: | August 7, 2013 |
Last Verified: | July 2013 |
cytomegalovirus infection infectious disease viremia cytomegalovirus disease stem cell transplant allogeneic bone marrow transplant |
hematopoietic cell transplant Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Myelodysplastic Syndrome |
Lymphoma Leukemia Preleukemia Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myeloid Hodgkin Disease Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Acute Myelodysplastic Syndromes |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Myeloproliferative Disorders |