Spots Global Cancer Trial Database for Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

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Trial Identification

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

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 ID: NCT00285259

Conditions

Acute Lymphoblastic Leukemia

Chronic Myelogenous Leukemia

Acute Myelogenous Leukemia

Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma

Myelodysplastic Syndrome

Interventions

VCL-CB01

Phosphate-buffered Saline (PBS)

Study Description

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.