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NCT Number: NCT00285259

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

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).

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Key information

Conditions

Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Bone Marrow Diseases Chronic Disease Chronic Myelogenous Leukemia Communicable Diseases Cytomegalovirus Infections DNA Virus Infections Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Hodgkin's Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Inflammation Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Sepsis Systemic Inflammatory Response Syndrome Viremia Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Cancer Center, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCL-CB01

Biological

5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients

Phosphate-Buffered Saline (PBS)

Other

1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Vical

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Feb 1, 2006
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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