NCT01673425终止不适用
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
National Center for Occupational Health and Infection Control1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- IgA Antibody Titers
研究概览
简要总结
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.
详细描述
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.
Specific Aims
- The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
- The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically eligible healthy men and women between the ages of 20 to 49 years old.
排除标准
- •A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
- •A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
- •Currently pregnant
- •Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
- •Have had flu within the current flu season.
- •Have had a flu vaccine within the current flu season.
- •Have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).
研究组 & 干预措施
Live Attenuated Influenza Vaccine
Experimental
Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
干预措施: Live Attenuated Influenza Vaccine (Drug)
结局指标
主要结局
IgA Antibody Titers
时间窗: Change from baseline in antibody titer at 6 weeks
次要结局
- Serum Antibody Response to LAIV(Change from baseline in serum antibody response at 6 weeks)
研究者
研究点 (1)
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