跳至主要内容
临床试验/NCT02249598
NCT02249598已完成不适用

Competitive Carriage of Neisseria Spp.; Discovering New Methods of Inhibiting Carriage of Neisseria Meningitidis (Lactamica 2)

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
The number of participants found to have carriage of the bacterium Neisseria meningitidis at 6 sampling points (culture of throat swaps) following innoculation as baseline of subjects with the bacterium Neisseria lactamica

研究概览

简要总结

In the future it is likely that we will replace the current schedule of injected vaccines with interventions that interrupt transmission of infections in more subtle ways. The agent that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of individuals. In most people, the bacterium is harmless and survives for months in the nasopharynx, however in a minority of people the bacteria can cause invasive disease.

Simply reducing colonisation amongst target groups may protect them, and the rest of the population as well. In a previous study we investigated cross protective antibodies, and found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless 'cousin' of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of a nasal medication. The proposed study large experimental challenge study funded by Meningitis UK that will aim to establish if N. lactamica does or does not inhibit colonisation by N. meningitidis. We will also determine whether N. lactamica displaces existing N. meningitidis carriage, and whether there are individuals who are innately resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages of 1830yrs from the two universities in Sheffield. It will involve placing droplets of N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like solution into the nose of the other half of volunteers. We will carry out nose swabs at intervals over a six month period to establish if the pattern of N.meningitidis carriage is effected by N.lactamica colonisation. If the findings are positive we will perform future mechanistic investigations. A62.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Currently healthy
  • Students and university employees from either Sheffield Hallam University or the University of Sheffield between the ages of 18 and 25yrs.
  • Fully conversant in the English language
  • Able to attend the full protocol timetable

排除标准

  • Individuals who are Immunocompromised due to a medical condition
  • Individuals taking immune modifying medications (not including inhaled steroids)
  • Individuals in close contact with immunocompromised people including medical students with full time clinical attachments.
  • Individuals who have an current infection
  • Current Smokers
  • People with an allergy to yeast extract.

结局指标

主要结局

The number of participants found to have carriage of the bacterium Neisseria meningitidis at 6 sampling points (culture of throat swaps) following innoculation as baseline of subjects with the bacterium Neisseria lactamica

时间窗: number of positive results presenting between day 0 (baseline) until study completion (28 weeks)

culture of throat swabs at 2 weeks, 4 weeks, 8 weeks, 16 weeks, 26 weeks and 28 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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