NCT01044095已完成不适用
Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine
Armed Forces Research Institute of Medical Sciences, Thailand1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- antibody titers
研究概览
简要总结
This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-49 years.
- •Healthy as determined by the PI or designate
- •Willing to give informed consent.
- •Willing to attend follow-up appointments and undergo study procedures.
- •US passport holder residing in Bangkok
- •If military, have a letter of approval for participation from the chain of command (Unit Commander).
排除标准
- •History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
- •Severe or life-threatening reaction to any previous vaccine.
- •History of chronic respiratory illness, including asthma and sinusitis.
- •History of heart disease
- •History of kidney disease
- •Metabolic disease such as diabetes
- •Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
- •History of Guillain-Barre syndrome.
- •Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
- •Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
- •Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
- •Blood donation within the preceding 3 months, or screening hemoglobin value of <12.5 g/dl.
- •Receipt of blood products including immunoglobulins within the preceding 3 months.
- •Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
- •Receipt of any antiviral agents within 48 hours of vaccine administration.
- •HIV positive on screening blood tests.
- •Any other condition that in the opinion of the study investigator warrants exclusion from the study.
结局指标
主要结局
antibody titers
时间窗: 12 weeks
次要结局
- safety of 2 doses of seasonal influenza vaccine in healthy adults(12 weeks)
研究者
研究点 (1)
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