A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 4
- 主要终点
- Safety, tolerability and local reactogenicity - AEs and laboratory parameters
研究概览
简要总结
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.
详细描述
Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages Eligible for Study:
- •18 Years - 50 Years
- •Genders Eligible for Study: Both
- •Accepts Healthy Volunteers
- •Inclusion Criteria:
- •Healthy adult volunteers (women must be of non child-bearing potential)
- •Provided written informed consent
排除标准
- •No significant concomitant illness
- •No allergy to gold
- •No immunosuppression due to disease or treatment
- •No previous flu vaccination in 2005 or 2006
结局指标
主要结局
Safety, tolerability and local reactogenicity - AEs and laboratory parameters
次要结局
- Immunogenicity of the vaccine