Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00285259
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

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

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT [ Time Frame: 1 year ]
  2. occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine. [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


  Show 22 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Vical
Investigators
Layout table for investigator information
Study Chair: Richard T. Kenney, MD Vical
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00285259     History of Changes
Other Study ID Numbers: CB01-202
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: July 2013

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