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The Development of a Human Model of Respiratory Syncytial Virus Infection

2015年6月3日 更新者:Imperial College London

The aim of this study is to understand the immune response (how the body fights infection) to Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold' illness in healthy adults, but can cause wheezing and lung problems in young infants and the elderly. The investigators want to understand why this is, in order to develop vaccines and treatments.

Participants will include 30-40 healthy adults age 18-55 years. Study procedures will include brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of fluid (lavage) and cells from the nose, throat and lungs. All participants will receive the virus via drops in the nose. The duration of the study for all subjects will be 6 weeks.

研究概览

详细说明

Bronchiolitis is the commonest cause of hospital admission in infants. It is caused by Respiratory Syncytial Virus(RSV), a virus that causes mild 'common colds' in adults, but can cause lung inflammation and difficulty breathing in infants and the elderly. In 2005, nearly 34 million cases in children <5 years occurred, resulting in 3.4 million hospital admissions,and around 120,000 deaths. There is no vaccine, and some previous vaccines actually made the disease worse.

The investigators have been trying to understand why for 40 years. Advances in immunology have given us a completely different way of looking at inflammation: rather than studying what causes it, the investigators now want to know what regulates it. Much of what the investigators know about how what causes and regulates inflammation has come from studies of animals, however, these do not exactly predict what happens in man.

The investigators therefore plan to infect healthy adult volunteers with RSV, and observe what happens in humans after RSV infection. The investigators will collect samples of blood, fluid and cells from the nose, throat, and lungs, and a diary of symptoms over four weeks. The investigators will analyse the blood, fluid, and cells to determine the important mechanisms that regulate inflammation in human RSV infection.

Studies like this have been conducted previously with no severe side effects. The investigators anticipate that the discoveries made in this research project will help us achieve a better understanding of what causes and regulates inflammation in RSV so that the investigators can learn ways to control it, with the aim of developing vaccines and treatments.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • London、英国、W2 1PG
        • St. Mary's Hospital, Imperial College London, Norfolk Place,

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy persons aged 18 to 55 years, able to give informed consent

Exclusion Criteria:

  • Chronic respiratory disease (asthma, COPD, rhinitis, sinusitis) in adulthood
  • Inhaled bronchodilator or steroid use within the last 12 months
  • Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
  • Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
  • Smoking in the past 6 months OR >5 pack-year lifetime history
  • Subjects with allergic symptoms present at baseline
  • Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease
  • Subjects with known or suspected immune deficiency
  • Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
  • History of frequent nose bleeds
  • Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
  • Pregnant or breastfeeding women

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Viral Challenge
Intranasal administration
其他名称:
  • M37

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Host response to RSV challenge
大体时间:Prior to and 0-28 days post challenge
The host response to RSV challenge will be assessed daily for 14 days using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids. This will be compared with that at baseline and at 28 days post challenge.
Prior to and 0-28 days post challenge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Peter Openshaw、Imperial College London

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年5月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2011年5月5日

首先提交符合 QC 标准的

2011年5月5日

首次发布 (估计)

2011年5月6日

研究记录更新

最后更新发布 (估计)

2015年6月4日

上次提交的符合 QC 标准的更新

2015年6月3日

最后验证

2012年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

RSV A Memphis 37的临床试验

3
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