NCT03721549已完成1 期
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
WCCT Global1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年10月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Frequency of Norovirus Gastroenteritis (NVG)
研究概览
简要总结
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor
- •Available for all planned visits and to spend at least 5 days in confinement
- •Confirmed blood type (A or O)
- •Demonstrated to be H type-1 antigen secretor positive (by saliva test)
- •Body mass index between 17 and 30 at screening
- •Female subjects must have a negative pregnancy test and either use contraceptives or be sterile
- •Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly
排除标准
- •Presence of significant medical condition
- •Donation or use of blood or blood products within 4 weeks prior to challenge
- •Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
- •Abnormal stool pattern
- •Any gastroenteritis within the past 2 weeks
- •Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.
研究组 & 干预措施
Moderate Dose Inoculum
Experimental
Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
干预措施: Norwalk GI.1 Virus (Biological)
Higher Dose Inoculum
Experimental
Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
干预措施: Norwalk GI.1 Virus (Biological)
结局指标
主要结局
Frequency of Norovirus Gastroenteritis (NVG)
时间窗: 7 days post-challenge
Occurrence of NVG within 7 days post-challenge
次要结局
- Frequency of Serious Adverse Events (SAEs)(42 ± 3 days post-challenge)
研究者
研究点 (1)
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