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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
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE February 1, 2006
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE January 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
  • Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT.
  • occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
Change History Complete list of historical versions of study NCT00285259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Official Title  ICMJE 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)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Acute Myelogenous Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Myelodysplastic Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: VCL-CB01
    Intervention: Biological: VCL-CB01
  • Placebo Comparator: Placebo
    PBS
    Intervention: Other: Phosphate-buffered Saline (PBS)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2012)
108
Original Enrollment  ICMJE
 (submitted: January 30, 2006)
160
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285259
Other Study ID Numbers  ICMJE CB01-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Vical
Investigators  ICMJE
Study Chair: Richard T. Kenney, MD Vical
PRS Account Astellas Pharma Inc
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP