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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 1

Conditions: Lymphoproliferative Disorder

Treatments: Biological: Inactivated EBV-infected vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00278200

J0216

P30CA006973 (U.S. NIH Grant/Contract)

NA_00046066 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

EBV Seronegative

Experimental group

Description:

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.

Treatment:

Biological: Inactivated EBV-infected vaccine

EBV Seropositive

Experimental group

Description:

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.

Treatment:

Biological: Inactivated EBV-infected vaccine