ISRCTN22467293已完成未知
Experimental Human Pneumococcal Challenge (EHPC) Model: Streptococcus pneumoniae Nasopharyngeal Experimental carriage study of Attenuated Strains (SNEAS) – proof of concept in healthy adults: working towards vaccines for pneumonia, a single-blind randomised controlled trial
iverpool School of Tropical Medicine0 个研究点目标入组 150 人开始时间: 2018年9月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33436429/ (added 07/01/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy volunteers
- •2. Age 18 – 50 years
- •3. Capacity to give informed consent
- •4. Ability to speak fluent English
排除标准
- •1. Research participant currently involved in another study unless observational or non-interventional
- •2. Participant in a previous EHPC trial
- •3. Natural carriers of S. pneumoniae identified following initial screening*
- •4. Vaccination: pneumococcal vaccination (routine in UK babies born since 2005 or US 2001)
- •5. Allergic to penicillin, amoxicillin
- •6. Health history:
- •6.1. Chronic ill health including, immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
- •6.2. Medication that may affect the immune system or clotting e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane or aspirin)
- •6.3. Recent antibiotics (within the last 4 weeks or long term for known active chronic infection)
- •6.4. Splenectomy
- •6.5. Current acute severe febrile illness
- •6.6. Major pneumococcal illness requiring hospitalization
- •6.7. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
- •7. Direct caring role or close contact with individuals at higher risk of infection:
- •7.1. Children under 5 years age
- •7.2. Chronic ill health or immunosuppressed adults
- •7.3. Adults over the age of 75 years
- •8. Smoker:
- •8.1. Current or ex-smoker in the last 6 months
- •8.2. Significant smoking history - more than 20 cigarettes per day for 10 years or the equivalent (> 10 pack years)
- •9. Women of child-bearing potential (WOCBP) who are:
- •9.1. Not deemed to have sufficient/effective birth control or confirmed abstinence
- •9.2. Pregnant
- •10. History of drug or alcohol abuse (at discretion of the clinician)
- •11. Overseas travel planned in follow up period (if unplanned contact team)
研究者
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