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

Study Overview
=================
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.

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)

Conditions
-----------------
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Biological: VCL-CB01
* Other: Phosphate-buffered Saline (PBS)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VCL-CB01<br> | Biological: VCL-CB01<br>* 5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients<br>|
| Placebo Comparator: Placebo<br>PBS | Other: Phosphate-buffered Saline (PBS)<br>* 1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
viremia, cytomegalovirus infection, infectious disease, 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