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

This study has been completed.
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00285259
First received: January 30, 2006
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: January 2006
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285259

  Show 22 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Vical
Investigators
Study Chair: Richard T. Kenney, MD Vical
  More Information

Publications:

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00285259     History of Changes
Other Study ID Numbers: CB01-202
Study First Received: January 30, 2006
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
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

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on June 17, 2013