NCT01335347已完成1 期
A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Frequency or severity of vaccine related events as measured through reported AEs
研究概览
简要总结
The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •In good health as established by medical history, physical examination and laboratory testing at the time of enrollment.
排除标准
- •Has had any other vaccines within the past 8 weeks.
- •Has had prior H5 avian influenza investigational vaccine.
- •Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
- •History of autoimmune related disease.
- •History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
- •Positive serology for HIV, HCV, or HBV.
- •Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain.
- •History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
- •Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
- •Stool sample with occult blood at baseline exam
研究组 & 干预措施
Experimental Low Dose
Experimental
Biological: One dose of a live replication incompetent adenovirus given in a capsule
干预措施: ND1.1 (Biological)
Experimental Medium Dose
Experimental
Biological: One or two doses of replication incompetent adenovirus given in a capsule
Other: Placebo capsules of the same size and shape
干预措施: ND1.1 (Biological)
Experimental High Dose
Experimental
Biological: One dose of replication incompetent adenovirus in a capsule
干预措施: ND1.1 (Biological)
Placebo Control
Placebo Comparator
Capsules of the same size and shape as the experimental
干预措施: Placebo control (Biological)
结局指标
主要结局
Frequency or severity of vaccine related events as measured through reported AEs
时间窗: up to 1 year
次要结局
- Magnitude of humoral immune responses to avian influenza as measured by functional assays(up to 1 year)
- Magnitude of cellular immune responses to avian influenza as measured by functional assays(up to 1 year)
研究者
研究点 (1)
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