Clinical Correlates of Immunologic Responses to the Flu Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of influenza infection in patients and healthy volunteers
研究概览
简要总结
RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant.
PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers.
详细描述
OBJECTIVES:
- To examine the incidence rate of influenza infection over two flu seasons in patients who have undergone hematopoietic stem cell transplantation at the City of Hope National Medical Center.
- To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.
- To examine and compare the incidence rate of influenza in healthy volunteers to the incidence rate in these patients.
OUTLINE: Beginning approximately 2 weeks after vaccination or the onset of flu season, patients and healthy participants undergo nasopharyngeal washes every 14-17 days (2-10 washes) during the months of November-March of the 2008-2009 and 2009-2010 flu seasons. Samples are analyzed by direct fluorescent antibodies.
Patients and participants complete case report forms detailing flu-like symptoms experienced in the 2 weeks before sample collection.
PROJECTED ACCRUAL: A total of 150 patients and 75 healthy volunteers will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following:
- •Patient at City of Hope or Kaiser hospital who underwent prior autologous or allogeneic matched-related hematopoietic stem cell transplantation (HSCT) or matched-unrelated HSCT for treatment of hematological malignancies, including aplastic anemia or myelodysplastic syndromes
- •Must agree to return to City of Hope for screening every 2-4 weeks during the flu season
- •100-365 days post-transplant
- •Any prior therapy allowed
- •Employee volunteer from the City of Hope who agrees to have a nasopharyngeal wash performed at General Clinical Research Center every 2 weeks during the flu season
- •Must be eligible (per physicians instructions) and vaccinated during the 2008-2009 or 2009-2010 flu season
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 9 months
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Incidence of influenza infection in patients and healthy volunteers
次要结局
- Vaccine protection
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients