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

Phase 2

Completed

• Conditions: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome; Acute Myelogenous Leukemia
• Interventions: Biological: VCL-CB01; Other: Phosphate-buffered Saline (PBS)

• Registration Number: NCT00285259
• Lead Sponsor: Astellas Pharma Inc

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 Timeline

• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study Start: 2006-01-31
• Study First Posted: 2006-02-01
• Primary Completion: 2009-11-30
• Study Completion: 2010-11-30
• Disposition First Submitted: 2013-07-31
• Disposition First Submitted QC: 2013-07-31
• Disposition First Posted: 2013-08-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VCL-CB01	VCL-CB01	-
Placebo	Phosphate-buffered Saline (PBS)	PBS

Primary Outcome Measures

Name	Time	Method
Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT	1 year
occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.	1 year

Trial Locations

Locations (22)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Hackensack University Medical Center # 408; 🇺🇸 Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States

North Carolina Baptist Hosptial; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Roswell Park Cancer Institute Corporation; 🇺🇸 Buffalo, New York, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

University of Kansas Medical Center; 🇺🇸 Westwood, Kansas, United States