EUCTR2012-005141-20-GB进行中（未招募）1 期
FULL TITLE: Pneumococcal Conjugate Vaccine (PCV-13) and Experimental Human Pneumococcal Carriage Study (EHPC) Study.KEY WORDS: mucosa, innate, cellular, humoral, Streptococcus pneumoniae, pneumococcus, carriage, colonisation, human, lung, antibody, vaccine, T-cells, genome sequencing, conjugate vaccine, protection. - PCV and EHPC Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adults aged 18-50 yrs old (chosen to minimise the risk of pneumococcal infection post inoculation)
- •2. Fluent English spoken (to ensure a comprehensive understanding of the research project and their involvement - this is predominately for safety reasons).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previously received PPV or any PCV vaccines (at any age) – full vaccine history obtained from General Practitioner as necessary
- •Previously lived in a hepatitis A endemic area
- •Previously received a complete course of hepatitis A vaccination
- •Previous significant adverse reaction to any vaccination/immunisation
- •Close contact with at risk individuals (children, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission
- •Current smoker or significant smoking history (>10 pack yrs) – to minimise risk of pneumococcal infection and optional bronchoscopy
- •Asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal infection
- •Pregnancy – to minimise risk of pneumococcal infection and no safety data exists for either vaccine in pregnancy
- •Breast-feeding mothers - no safety data exists for either vaccine in pregnancy
- •Women of child-bearing potential (WOCBP) who are deemed not to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination
- •Allergic to penicillin/amoxicillin
- •Involved in another clinical trial unless observational or in follow-up (non-interventional) phase
- •Previously been involved in a clinical trial involving experimental human pneumococcal carriage
- •Unable to give fully informed consent
- •Medication that may affect the immune system (e.g. steroids, steroid nasal spray)
- •Current acute severe febrile illness at the time of vaccination/inoculation.
研究者
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