PACTR202309751708712尚未招募Unknown
Serotype 3 Dose ranging and reproducibility Experimental Human Pneumococcal Challenge in healthy volunteers
iverpool School of Tropical Medicine0 个研究点目标入组 83 人开始时间: 2023年8月31日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 83
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
- •Healthy adults aged 18-50 years.
- •Fluent spoken English and/or Chichewa.
- •Capacity to give informed consent
- •HIV negative
- •Access to their own mobile telephone
排除标准
- •Currently involved in another study unless observational or non-interventional.
- •Participant in any previous EHPC trial in past year
- •Previous pneumococcal vaccination. This can be self-reported or confirmed from the health passport if deemed necessary at clinician discretion.
- •HIV positive
- •Allergy to penicillin/amoxicillin
- •Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease.
- •Medication that may affect the immune system e.g., steroids, inflammation altering or disease-modifying anti-rheumatoid drugs.
- •Long term use of antibiotics for chronic infection.
- •Major pneumococcal illness requiring hospitalisation in the last 10 years.
- •Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
- •Significant mental health problems (uncontrolled condition or requiring previous admission to a psychiatric unit) that would impair ability to participate
- •Direct caring role or close contact with individuals at higher risk of infection; Children under 5 years age, adults with chronic ill health or immunosuppression, hospital patients
- •Current or ex-smoker (daily cigarettes, daily e-cigarettes/vaping and daily smoking of recreational drugs) in the last 6 months. Participants who smoke <5 cigarettes per week may be included. Previous significant smoking history (>20 cigarettes per day for 20 years or equivalent [>20 pack years].
- •Currently pregnant/lactating/ Intending on becoming pregnant during the study
- •History of or current drug or alcohol abuse; Men should not drink >3 units/day regularly. Women should not drink >2 units/day regularly.
- •Overseas travel planned in follow up period of study visits
- •Natural SPN3 colonisation in baseline nasal wash
研究者
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