A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety and Immunogenicity of an Adenoviral-vector Based Oral Norovirus Vaccine Expressing GI.1 VP1 Administered Orally to Health Stable Older Adult Volunteers 55-80 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Rate of Solicited Adverse Events
研究概览
简要总结
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
详细描述
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old).
Subjects will we randomized in the study utilizing an age and dose escalation schedule. A Safety Monitoring Committee will provide oversight of the trial throughout the duration of the 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of Solicited Adverse Events
时间窗: Day 1 (Vaccination) to 7 days post vaccination
Safety
Rate of Unsolicited Adverse Events
时间窗: Day 1 (Vaccination) to 28 days post vaccination
Safety
次要结局
- VP1 specific IgA ASC(Day 1 (Vaccination) to 7 days post vaccination)
- Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)(Day 1 (Vaccination) to 7 days post vaccination)
- VP1 specific serum IgG(Day 1 (Vaccination) to 7 days post vaccination)