ISRCTN71362981进行中（未招募）Unknown
Experimental human pneumococcal challenge - serotype 6B in older adults
iverpool School of Tropical Medicine0 个研究点目标入组 15 人开始时间: 2024年4月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •1. Healthy adults aged 50-84 (inclusive, at the time of consent and inoculation) years old
- •2. World Health Organisation performance status 0 (able to carry out all normal activity without restriction) or 1 (restricted in strenuous activity but ambulatory and able to carry out light work)
- •3. Access to telephone and e-mail
- •4. Fluent spoken English – to ensure a comprehensive understanding of the research project
- •5. Capacity to provide written informed consent in English
排除标准
- •Individuals may not participate in the study if they are/have:
- •Research participant:
- •1. Currently involved in another study unless observational or non-interventional, excluding the EHPC bronchoscopy study (at the discretion of the study team) and exceptions may be applied at the discretion of the CI/PI to ensure no harm comes to the participants (e.g. excessive blood or nasal sampling)
- •2. Participated in a previous Spn6B EHPC study within 3 years
- •Nasal carriage:
- •Participants who have natural pneumococcal identified at screening
- •Vaccination:
- •1. Had any vaccination within 28 days of enrolment (defined as the time of inoculation) other than against influenza or COVID-19 which is permissible up to 14 days before inoculation
- •2. Had a pneumococcal conjugate vaccine*
- •Allergy to beta-lactam antibiotics (including penicillin and amoxicillin)
- •Medical history leading to increased risk of severe infection, illness including but not limited to:
- •1. Asplenia or dysfunction of the spleen
- •2. Chronic respiratory disease (e.g. asthma [requiring medication (including salbutamol inhaler) within last 12 months], COPD, bronchiectasis and sleep apnoea)
- •3. Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) - controlled and stable hypertension may be included
- •4. Chronic kidney disease (e.g. kidney transplant, regular dialysis, CKD3-5)
- •5. Chronic liver disease (e.g. cirrhosis, hepatitis)
- •6. Chronic neurological disease that limits mobility, bulbar or respiratory function (including stroke, Parkinson’s disease, dementia and multiple sclerosis)
- •7. Diabetes mellitus (including diet controlled)
- •8. Cancer within the past 5 years (except for basal cell carcinoma of the skin, melanoma in situ and cervical carcinoma in situ)
- •9. Receipt of immunosuppressive therapy such as anti-cancer immunotherapy, chemotherapy or radiation therapy within the preceding 5 years or long-term systemic corticosteroid, Roaccutane, or disease-modifying anti-rheumatoid drugs therapy (for more than 7 consecutive days within the 3 months before enrolment)
- •10. Individuals with cochlear ear implants
- •11. Individuals with major cerebrospinal fluid leaks (e.g. following traumatic, major skull surgery, or requiring CSF shunts)
- •12. Subjects with known or suspected immune deficiency (e.g. HIV, known IgA deficiency, immotile cilia syndrome, or Kartagener’s syndrome)
- •13. History of frequent nose bleeds
- •14. Bleeding disorders
- •15. Significant mental health disorders
- •16. Other uncontrolled comorbidities, as determined by the clinical investigator, which would be expected to increase the risk of pneumococcal disease
- •17. Any major pneumococcal illness or pneumonia requiring hospitalisation in the last 10 years
- •18. Meeting STOP criteria
- •1. Any medication that may affect the immune system in the last 3 months (e.g. systemic steroids [IM/IV], steroid nasal spray, Roaccutane, disease-modifying anti-rheumatoid drugs)
- •2. Long-term antibiotic use or any antibiotics (other than topical) in the past 28 days
- •3. Recipient of monoclonal antibodies for any indication
- •4. Recipient of blood transfusion products within the last year
- •5. Any medication that may affect the coagulation system in the last 3 months (excluding low-dose aspirin)
- •6. Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 1 month
- •1. Pregnancy
- •2. Lactation
- •3. Intend t
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