Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder
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|ClinicalTrials.gov Identifier: NCT00278200|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2006
Last Update Posted : November 2, 2015
RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoproliferative Disorder||Biological: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine||Phase 1|
- Determine the efficacy of photochemically-treated autologous Epstein-Barr virus (EBV)-transformed B-lymphoblastoid cell vaccine in generating an EBV-specific T-cell and antibody response in EBV-negative patients or in boosting the response in EBV-positive patients who are being considered for a solid organ transplant and are at high risk for post-transplant lymphoproliferative disorder.
- Determine adverse events associated with this vaccine in these patients.
- Determine the ability of the vaccine to protect from EBV primary infection in EBV-seronegative patients during the time course of the study.
OUTLINE: This is a nonrandomized, pilot study. Patients are stratified according to Epstein-Barr virus (EBV) status (seropositive vs seronegative).
Patients receive photochemically-treated autologous EBV-transformed B-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine|
|Study Start Date :||September 2002|
|Estimated Primary Completion Date :||December 2021|
|Study Completion Date :||December 2022|
- Efficacy of vaccine [ Time Frame: 15 years ]
- Adverse events associated with the vaccine [ Time Frame: 15 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278200
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Richard F. Ambinder, MD, PhD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|