ISRCTN15728847已完成4 期
A phase IV double-blind randomised controlled trial (DBRCT) to investigate the effect of PCV-13 and PPV-23 on pneumococcal colonisation using the experimental human pneumococcal challenge (EHPC) model in healthy adults
iverpool School of Tropical Medicine0 个研究点目标入组 516 人开始时间: 2021年6月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 516
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35798520/ (added 08/07/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/04/2022:
- •1. Aged 18 to 50 years
- •2. Speak English fluently (to ensure a comprehensive understanding of the research project and proposed involvement)
- •3. Have the capacity to give informed consent
- •4. Have a urine pregnancy test and agree to use adequate contraception during the study (if able to bear children)
- •Previous inclusion criteria:
- •1. Aged 60 to 69 years
- •2. Speak English fluently (to ensure a comprehensive understanding of the research project and proposed involvement)
- •3. Have the capacity to give informed consent
- •4. Have a urine pregnancy test and agree to use adequate contraception during the study (if able to bear children)
排除标准
- •1. Currently involved in another research study (unless observational or non-interventional)
- •2. Involved in a previous EHPC study in the last 3 years involving exposure to pneumococcus
- •3. Previously received a pneumococcal vaccination
- •4. Allergy to penicillin or amoxicillin
- •5. Have had a severe, life-threatening allergic reaction to a vaccine
- •6. Chronic ill-health, including but not limited to problems with the immune system, diabetes, asthma requiring regular medication, recurring ear infections, COPD, major heart/lung disease, cancer, and rheumatoid arthritis
- •7. Taking medication that may affect the immune system, including but not limited to steroids, nasal steroids, Roaccutane, and anti-rheumatoid drugs
- •7. Recent antibiotics, either within the last 28 days or long-term for a chronic infection
- •8. Pneumococcal illness requiring a stay in a hospital within the last 10 years
- •9. Any other condition that is deemed to possibly put personal safety or the study at risk as decided by the clinical team
- •10. Employed in a direct caring role or close contact with individuals at higher risk of infection on a regular basis during the study, including but not limited to children under 5, and people with chronic ill-health or immunosuppression
- •11. Current smoker, or ex-smoker who has quit within the last 6 months, of regular cigarettes, cigars, e-cigarettes, vapes, and/or recreational drugs
- •12. Previous significant smoking history of >20 pack-years (20 cigarettes per day for 20 years or equivalent)
- •13. Pregnant, lactating or intending on becoming pregnant during the study
- •14. History or current drug or alcohol abuse as assessed by the clinical team
- •15. Overseas travel planned during the exposure stages of the study which is defined as the time of inoculation until the use of antibiotics
- •16. Natural pneumococcal carriage. It is anticipated that 10-15% of participants will have a natural pneumococcal carriage at the time of recruitment. Testing will be repeated a few weeks after the initial screening appointment to check if carrier status has changed.
研究者
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