Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy of Vaccine as Assessed by T-cell Responses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
EBV Seronegative
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.
干预措施: Inactivated EBV-infected vaccine (Biological)
EBV Seropositive
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.
干预措施: Inactivated EBV-infected vaccine (Biological)
结局指标
主要结局
Efficacy of Vaccine as Assessed by T-cell Responses
时间窗: Up to 67 days
Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.
次要结局
- Adverse Events Associated With the Vaccine(Up to 5 years)
- Prevention of Primary Epstein-Barr Virus (EBV) Infection(Up to 5 years)