Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
- 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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Efficacy of vaccine
Richard F. Ambinder, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|