MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Number of Subjects With T-Cell Based Immune Response to Vaccine
研究概览
简要总结
Study Design:
This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Population
- •HSCT recipients who are greater than 60 days post transplant.
- •Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
- •Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no known disease relapse
- •No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
- •No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
- •Controls:
- •Age 18 to 50 years
- •No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
- •No flu vaccine in previous 4 months
排除标准
- 未提供
研究组 & 干预措施
Participants Receiving 2 Doses of Vaccine
Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.
干预措施: Influenza vaccine (Biological)
Participants Receiving 1 Dose of Vaccine
Control group participants (healthy volunteers):
- Age 18 to 50 years
- No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
- No flu vaccine in previous 4 months
and/or HSCT recipients who are greater than 60 days post transplant.
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Number of Subjects With T-Cell Based Immune Response to Vaccine
时间窗: 8 Weeks After Vaccination
The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.
次要结局
- Number of Subjects With H3 Based Immune Response to Vaccine(8 Weeks After Vaccination)