Trial Information

Summary: A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenecity and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched, Related Hematpoietic Cell Transplant (HCT)

FOR THE DONOR

You have been asked to participate in this research study because you are planning to donate peripheral blood stem cells (PBSC, immature cells that can become blood cells) for a relative undergoing a hematopoietic cell transplant (HCT).  You must voluntarily give informed consent to participate in this clinical study.  The purpose of this study is to compare an investigational CMV vaccine with a placebo (an injection that contains no medication) in terms of safety and ability to create antibodies to CMV.  Another goal is to see if transplant recipients who receive the investigational CMV vaccine and stem cells from donors, who also received the investigational CMV vaccine, have less evidence of CMV infection than those who receive the placebo and stem cells from donors who also received the placebo.  Your participation in this study is expected to last approximately 12 weeks for treatment and approximately 6 months for follow-up.

FOR THE RECIPIENT

You have been asked to participate in this research study because you are planning to undergo hematopoietic cell transplant (HCT) and have previously been infected with CMV (have antibodies to CMV).  You must both voluntarily give informed consent to participate in this clinical study.  The purpose of this study is to compare an investigational CMV vaccine with a placebo (an injection that contains no medication) in terms of safety and ability to create antibodies to CMV.  Another goal is to see if transplant recipients who receive the investigational CMV vaccine and stem cells from donors who have or have not also received the investigational CMV vaccine have less evidence of CMV infection than those who receive the placebo and stem cells from donors who have or have not also received the placebo.  Your participation in this study is expected to last approximately 12 weeks for treatment and approximately 1 year for follow-up.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:31:14 PM