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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278200
Recruitment Status : Active, not recruiting
First Posted : January 18, 2006
Last Update Posted : November 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoproliferative Disorder Biological: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine Phase 1

Detailed Description:



  • 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
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
Study Start Date : September 2002
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Primary Outcome Measures :
  1. Efficacy of vaccine [ Time Frame: 15 years ]

Secondary Outcome Measures :
  1. Adverse events associated with the vaccine [ Time Frame: 15 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Being considered for a solid organ transplant
  • At high risk for post-transplant lymphoproliferative disorder


  • Body weight ≥ 25 kg
  • Karnofsky performance status 50-100% OR
  • Lansky performance status 50-100%
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use contraception during and for 2 months after completion of study treatment
  • Hemoglobin ≥ 8 g/dL (erythropoietin allowed)
  • No history of autoimmune disease, including any of the following:

    • Systemic lupus erythematosus
    • Sarcoidosis
    • Rheumatoid arthritis
    • Glomerulonephritis
    • Vasculitis
  • No primary immunodeficiency
  • No HIV positivity


  • No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:

    • Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency
    • Inhaled steroids

Information from the National Library of Medicine

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 identifier (NCT number): NCT00278200

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Richard F. Ambinder, MD, PhD Sidney Kimmel Comprehensive Cancer Center

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00278200     History of Changes
Other Study ID Numbers: CDR0000445433 J0216
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
post-transplant lymphoproliferative disorder

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs