PACTR202008503507113招募中3 期
The Influence of Pneumococcal Conjugate Vaccine-13 on Nasal Colonisation in a Controlled Human Infection Model of Pneumococcal Carriage in Malawi v1.3 05 Jan 2022
iverpool School of Tropical Medicine0 个研究点目标入组 200 人开始时间: 2020年6月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-40 years - ages chosen to minimise the risk of pneumococcal infection
- •Fluent spoken and written Chichewa or English - to ensure a comprehensive understanding of the research project, their proposed involvement and communication with all members of the research team
排除标准
- •Previous pneumococcal vaccination.
- •COVID-19 positive at time of screening tests
- •HIV-infection sero positive. HIV self-test kits will be used by participants to confirm infection status in the presence of the research team. Any seropositive participant will be referred to trained personnel certified in HIV Testing Services (HTS) for confirmatory Determine” and Unigold” tests. Any participants confirmed as HIV-infection positive will be referred to the governmental system for infection confirmation, treatment and follow up.
- •Close physical contact (e.g. sleeping in the same room or nursing) with at-risk individuals (children under 5 years age, immunosuppressed adults, elderly, chronic ill health).
- •Allergy to penicillin/amoxicillin.
- •Acute illness (current illness, Acute illness within 3 days prior to inoculation, Antibiotic treatment within 2 weeks of inoculation).
- •Chronic illness that may impair immune response or impair ability to comply with study procedures and safety monitoring (e.g. HIV, diabetes).
- •Taking immunosuppressive medication that may include but is not limited to steroids and steroid nasal spray.
- •Pregnancy - minimise risk of pneumococcal disease.
- •Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
- •History of drug or alcohol abuse. This is very difficult to ascertain in a history therefore we will exclude people reporting drinking alcohol more than twice per week.
- •History of Smoking (Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease)
- •Unable to give informed consent.
- •In case of any uncertainty or concern, the PI will take clinical responsibility for the decision.
- •Participant is positive for Streptococcus pneumoniae serotype 6B on nasal wash sample at visit C. Cur
研究者
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