Immune Response to Neoantigen and Recall Antigen in Pediatric Renal Transplant Recipients Treated With the IL-2R Alfa Monoclonal Antibody, Daclizumab (Zenapax®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization
研究概览
简要总结
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.
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
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary renal transplant recipients between 2 and 19 years of age
- •Receiving or have received daclizumab in the previous 4-18 months
- •Receiving or have received daclizumab less than (<) 24 hours pretransplant and additional courses every other week
- •Single organ recipients (kidney only)
- •Previous vaccination with tetanus toxoid (TT) prior to transplant
- •Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid)
排除标准
- •Received intravenous gamma globulin or a TT vaccination since transplant
- •Experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations
- •Received any vaccine within 30 days of receiving study vaccinations
- •Received plasmapheresis treatment or growth hormone treatment since transplant
研究组 & 干预措施
Group A (With Daclizumab Therapy)
Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram [mg/kg]) with Day 1 vaccine administered immediately prior to the fifth dose.
干预措施: DT (Biological)
Group A (With Daclizumab Therapy)
Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram [mg/kg]) with Day 1 vaccine administered immediately prior to the fifth dose.
干预措施: Daclizumab (Drug)
Group A (With Daclizumab Therapy)
Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram [mg/kg]) with Day 1 vaccine administered immediately prior to the fifth dose.
干预措施: KLH (Biological)
Group B (Post Daclizumab Therapy)
Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.
干预措施: DT (Biological)
Group B (Post Daclizumab Therapy)
Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.
干预措施: KLH (Biological)
结局指标
主要结局
Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization
时间窗: Baseline and Day 43 or Day 57
Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).
次要结局
- Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)(Baseline, Day 22, Day 29, Day 43 and Day 57)
- Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations(Baseline, Day 22, Day 29, Day 43 and Day 57)
- Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization(Up to Day 252)
- Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response(up to Day 252)
- Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)(Screening, Day 22, Day 29, Day 43 and Day 57)
- Mean Percent Expression of 2A3/CD25+ Antibody(Screening, Day 29, Day 57 and Day 168)
- Mean Percent Expression of CD3, CD4, and CD8(Days 1, 22, 29, 43 and 57)
- Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+(Days 1, 29 and 57)
- Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6(Month 6)
- Number of Participants Who Developed a Positive Cellular Response to KLH Immunization(Baseline, Day 22, Day 29, Day 43, and Day 57)
- Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization(Baseline, Day 22, Day 29, Day 43 and Day 57)
- Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)(Baseline, Day 22, Day 29, Day 43 and Day 57)
- Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response(Up to Day 252)
- Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization(Day 1 and Day 29)
- Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)(Up to Month 12)