Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
研究概览
简要总结
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
详细描述
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
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
- •Positive for H1 influenza by HAI.
- •Has had an influenza vaccine in the past 2 years.
- •Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
- •History of any confirmed or suspected immunodeficient or immunosuppressive condition
- •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 of the vaccine targeting the mucosa of the small intestine
- •Use of proton pump inhibitors(Nexium, Prilosec).
- •Stool sample with occult blood at baseline exam
结局指标
主要结局
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
时间窗: One year following last vaccination
次要结局
- Magnitude of humoral immune response to influenza as measured by functional assays(28 Days and 180 Days post-vaccination)
- Magnitude of cellular immune responses to influenza as measured by functional assays(28 Days and 180 Days post-vaccination)