Specialty: Infectious diseases and microbiology, Primary sub-specialty: Antimicrobial Research
Conditions
Interventions
Healthy non-smoking adult participant’s are exposed with well-characterised, fully sequenced penicillin-sensitive pneumococci and observe them for the development of pneumococcal carriage.
Sponsors
Royal Liverpool and Broadgreen University Hospitals
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 years ages (chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group) 2. Fluent spoken English (to ensure a comprehensive understanding of the research project and their proposed involvement)
Exclusion criteria
Exclusion criteria: 1. Previous pneumococcal vaccination 2. History of pneumococcal illness 3. Close physical contact with at risk individuals (children under 5yrs, immunosuppressed adults, elderly, chronic ill health) -to minimise risk of pneumococcal transmission 4. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection 5. Allergy to penicillin/amoxicillin 6. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics. Also medication that may reduce immunity eg. Roacutanne 7. Current illness, acute illness within 3 days prior to inoculation or antibiotic treatment within 2 weeks of inoculation 8. Pregnancy - minimise risk of pneumococcal disease 9. Diagnosed as diabetic 10. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 11. Have been involved in a clinical trial involving EHPC and bacterial inoculation 12. History of drug or alcohol abuse 13. Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease 14. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease 15. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease 16. Unable to give fully informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inoculated pneumococci is assessed using classical culture methods at any time point from nasal wash recovered from the participants at days 2, 7 and 14 following first pneumococcal challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Factors local to the nasal mucosa which determine the probability or intensity of colonisation (levels of inflammation as measure by cytokines and cellular infiltration measure by flow cytometry) are measured using the nasal cells at days two, seven and 14 following first pneumococcal challenge. 2. Protective effect of carriage against the reacquisition of carriage following inoculation with a different pneumococcal strain to be evaluated after the repeat study on days two and seven following second pneumococcal inoculation. | — |
Countries
United Kingdom
Contacts
Public ContactVictoria Connor
Outcome results
None listed