Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder
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.
Biological: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine|
- Efficacy of vaccine [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Adverse events associated with the vaccine [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||December 2021 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|