Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder

2014-08-27 03:46:39 | BioPortfolio


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.




- 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 Design

Allocation: Non-Randomized, Primary Purpose: Treatment


Lymphoproliferative Disorder


autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
United States


Active, not recruiting


Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:46:39-0400

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An extranodal neoplasm, usually possessing an NK-cell phenotype and associated with EPSTEIN-BARR VIRUS. These lymphomas exhibit a broad morphologic spectrum, frequent necrosis, angioinvasion, and most commonly present in the midfacial region, but also in other extranodal sites.

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A genus of the family HERPESVIRIDAE, subfamily GAMMAHERPESVIRINAE, infecting B-cells in humans and new world primates. The type species human herpesvirus 4 (HERPESVIRUS 4, HUMAN) is better known as the Epstein-Barr virus.

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