Experimental Human Pneumococcal Carriage model: Research working towards a nasal vaccine for pneumonia: The effect of new strains (types) of bacteria in healthy participants.

Royal Liverpool and Broadgreen University Hospitals0 个研究点目标入组 134 人开始时间: 2017年8月15日最近更新: 2019年9月2日

适应症

试验速览

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•1. Adults aged 18-50 years ages (chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group)
•2. Fluent spoken English (to ensure a comprehensive understanding of the research project and their proposed involvement)

•1. Previous pneumococcal vaccination
•2. History of pneumococcal illness
•3. Close physical contact with at risk individuals (children under 5yrs, immunosuppressed adults, elderly, chronic ill health) -to minimise risk of pneumococcal transmission
•4. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection
•5. Allergy to penicillin/amoxicillin
•6. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics. Also medication that may reduce immunity eg. Roacutanne
•7. Current illness, acute illness within 3 days prior to inoculation or antibiotic treatment within 2 weeks of inoculation
•8. Pregnancy - minimise risk of pneumococcal disease
•9. Diagnosed as diabetic
•10. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
•11. Have been involved in a clinical trial involving EHPC and bacterial inoculation
•12. History of drug or alcohol abuse
•13. Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease
•14. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease
•15. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease
•16. Unable to give fully informed consent

发起方

Royal Liverpool and Broadgreen University Hospitals