ISRCTN17879306已完成未知
Serotype 3 experimental human pneumococcal challenge; dose-ranging and reproducibility in a healthy volunteer population
iverpool School of Tropical Medicine0 个研究点目标入组 90 人开始时间: 2022年4月4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
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Healthy young adults aged 18-50 years (inclusive). This age range minimises the risk of invasive pneumococcal infection and allows 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, enabling valid consent to be given
- •3. Access to their own mobile telephone - to ensure safety and timely communication
- •4. Capacity to give informed consent
排除标准
- •1. Currently involved in another study unless observational or non-interventional, excluding the EHPC bronchoscopy study (at the discretion of the study team). This is to ensure no harm comes to the participants through over-sampling.
- •2. Participant in any previous EHPC trial in the past year
- •3. Participant in previous EHPC trial inoculated with SPN3 in the last 3 years
- •4. Participant in EHPC Pneumo 2 trial
- •5. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in babies born in the UK since 2005) or PCV10. This can be self-reported or confirmed from GP questionnaire (GPQ) if deemed necessary at clinician discretion.
- •6. Allergy to penicillin/amoxicillin
- •7. Health history (self-reported or confirmed by GPQ or medical summary if felt to be necessary at clinician discretion):
- •8. Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
- •9. Medication that may affect the immune system e.g., steroids, inflammation altering or disease-modifying anti-rheumatoid drugs
- •10. Long term use of antibiotics for chronic infection
- •11. Major pneumococcal illness requiring hospitalisation in the last 10 years
- •12. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
- •13. Significant mental health problems (uncontrolled condition or requiring previous admission to a psychiatric unit) that would impair ability to participate
- •14. Direct caring role or close contact with individuals at higher risk of infection during the inoculation period if personal protective equipment (PPE) not worn:
- •14.1. Children under 5 years of age
- •14.2. Adults with chronic ill health or immunosuppression
- •14.3. Hospital patients
- •15. 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.
- •16. Previous significant smoking history (>20 cigarettes per day for 20 years or equivalent [>20 pack years])
- •17. Biologically female participants of child-bearing potential (WOCBP) who are:
- •17.1. Currently pregnant/lactating
- •17.2. Intending on becoming pregnant during the study
- •17.3. Not deemed to have effective birth control
- •18. History of or current drug or alcohol abuse:
- •18.1. Men should not drink >3 units/day regularly
- •18.2. Women should not drink >2 units/day regularly
- •19. Overseas travel planned in follow up period of study visits
- •20. Natural SPN3 colonisation in baseline nasal wash – if a participant is colonised with non-SPN3 pneumococcus, they can be included as part of exploratory analyses, but would not be included in the primary analysis
- •21. STOP criteria – participants who meet STOP criteria at the time of screening:
- •21.1. Clinical history and examination: STOP if unexplained or concerning findings on history or examination
- •21.2. Severe adverse event (SAE) or research-related injury (RRI): STOP if related SAE or RRI reported
- •21.3. Engagement with research team: STOP if the research team have concerns about the participant’s ability to commit to frequent communication and safety checks
- •21.4. Full blood count (FBC):
- •21.5.1. STOP if Hb <10 g/l
- •21.5.2. STOP if total WCC <1.5 x 10e9/l
- •21.5.3. STOP if total WCC >12 x 10e9/l
- •21.5.4. STOP if platelets <75 x 10e9/l
- •21.6. Resting SpO2: STOP if <94%
- •21.7. Illness during the study: STOP if participant develops a me
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