Experimental human pneumococcal challenge - serotype 6B in older adults

iverpool School of Tropical Medicine0 个研究点目标入组 15 人2024年4月12日

概览

暂无简介。

注册库

who.int

开始日期

2024年4月12日

结束日期

2025年10月30日

最后更新

去年

研究类型

Interventional

性别

All

发起方

iverpool School of Tropical Medicine

•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

•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)