Discovering New Treatments for Asthma and COPD. The Use of the Human Viral Challenge Model With a Newly Manufactured and Characterised GMP Wild-Type Human Rhinovirus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hvivo
- 入组人数
- 17
- 主要终点
- Virus shedding defined as area under the curve
研究概览
简要总结
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.
详细描述
Human Rhinovirus infection is an important precursor to asthma and chronic obstructive pulmonary disease exacerbations and the Human Viral Challenge model may provide a powerful tool in studying these and other chronic respiratory diseases. In this study we have reported the production and human characterisation of a new HRV-16 challenge virus produced specifically for this purpose.
An HRV-16 isolate from an 18 year old experimentally infected healthy female volunteer (University of Virginia Children's Hospital, USA) was obtained with appropriate medical history and consent. We manufactured a new HRV-16 stock by minimal passage in a WI-38 cell line under Good Manufacturing Practice conditions. Having first subjected the stock to rigorous adventitious agent testing and determining the virus suitability for human use, we conducted an initial safety and pathogenicity clinical study in adult volunteers in our dedicated clinical quarantine facility in London.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- •Female subjects were required to provide of a history of reliable contraceptive practice.
排除标准
- •hypersensitivity to mercurials or chicken eggs,
- •anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints,
- •abnormal electrocardiogram (ECG),
- •febrile illness or significant symptoms of upper respiratory infection on the day of
- •Subjects using medication or other products for rhinitis or nasal congestion,
- •Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
- •Subjects agreed not to smoke during the quarantine phase.
研究组 & 干预措施
Titre 1
Low infectious titre of innoculum
干预措施: Titre 1 (Other)
Titre 2
Medium infectious titre of innoculum
干预措施: Titre 2 (Other)
Titre 3
High infectious titre of innoculum
干预措施: Titre 3 (Other)
结局指标
主要结局
Virus shedding defined as area under the curve
时间窗: 10 days
次要结局
- Symptoms of respiratory tract infection(10 days)