NCT00278200

Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD

Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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.

Conditions

• Lymphoproliferative Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated EBV-infected vaccine

Timeline

• Start date: 2003-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2006-01-18
• Last updated: 2023-04-25
• Results posted: 2019-02-26

Locations

1 site across 1 country: United States