Pilot Study of Repeated Mucosal Sampling on EHPC model
Research type
Research Study
Full title
Pilot Study of Repeated Mucosal Sampling on Experimental Human Pneumococcal Colonisation (EHPC) Model
IRAS ID
170345
Contact name
Stephen Gordon
Contact email
Sponsor organisation
Royal Liverpool University Hospital
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Asymptomatic carriage of Streptococcus pneumoniae (pneumococcus) in the nose occurs prior to the onset of significant infections, including pneumonia and septicaemia. Our group has established a safe and reproducible experimental human pneumococcal colonisation (EHPC) model to improve our understanding of the complex interplay between colonisation and immune response. The purpose of this study is to determine if repeated mucosal sampling (lining of the nose) will obtain enough tissue for immunological assessment. We also want to evaluate if the repeated sampling affects the aquisition, density of pneumococcus in the nose, immune response and volunteers’ comfort levels. This study’s results will be essential for future larger research studies.
The work will be conducted in the Clinical Research Unit in the Royal Liverpool University Hospital, an MHRA-approved Phase 1 unit with 24/7 medical cover. Sample analysis will be performed by trained staff in Liverpool School of Tropical Medicine. Healthy non-smoker adult volunteers (with no close contact with young children or disease-susceptible adults) will be recruited and inoculated with a penicillin-susceptible strain of pneumococcus (serotype 6B) in their nose. Nasal sampling will occur prior to pneumococcal inoculation and post-inoculation on days 2, 7, 9 and 14. Sampling will consist of: (1) nasosorption, using absorptive blotting paper to collect nasal secretions (2) nasal washes, a well-established technique involving the instillation and expulsion of saline and (3) nasosampling, gentle scraping of the mucosa to collect cells. Participants will be monitored for symptoms of infection daily for the first week post-inoculation and provided with antibiotics and emergency contact details. Blood samples will be collected for clinical monitoring, to investigate the systemic immune response and check for migration of pneumococcus into the bloodstream. Comfort of sampling will be evaluated using a Likert scale. An optional research bronchoscopy and bronchoalveolar lavage will also be offered to collect supplementary data.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0146
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion