Healthy volunteers Not Applicable
Conditions
Interventions
The initial stage of the study involves healthy volunteers 18-50yrs old. These participants will be nasally inoculated with a dose of live pneumococcal bacteria: SPN3. The dose inoculated will be eith
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy young adults aged 18-50 years (inclusive) - ages chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group. 2. Healthy older participants group only- adults aged 60-69 years (inclusive) 3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 4. Access to their own mobile telephone - to ensure safety and timely communication 5. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Currently involved in another study unless observational or non-interventional except for the EHPC bronchoscopy study* 2. Participant in a previous EHPC trial within the last 3 years (at the discretion of the study team ie. Not inoculated nasally with pneumococcus) 3. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in UK babies born since 2005 or US 2001) or PCV10. 4. Allergy: to penicillin or amoxicillin 5. Chronic ill health including, immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease 6. Medication that may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane) or disease-modifying anti-rheumatoid drugs. 7. Recent antibiotics (within the last 28 days or long term for known active chronic infection) 8. Current illness or acute illness within 14 days prior to inoculation 9. Major pneumococcal illness requiring hospitalisation 10. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study 11. Direct caring role or close contact with individuals at higher risk of infection (children under 5 years age, chronic ill health or immunosuppressed adults) 12. Current or ex-smoker (regular cigarettes, regular e-cigarette/vaping and regular smoking of recreational drugs) in the last 6 months 13. Previous significant smoking history - more than 20 cigarettes per day for 20 years or the equivalent (>20 pack years) 14. Women of child-bearing potential (WOCBP) who are: 14.1 Not deemed to have sufficient/effective birth control or confirmed abstinence 14.2 Pregnant 15. History or current drug or alcohol abuse (frequently drinking alcohol: men and women should not regularly drink >3 units/day and >2 units/day respectively) at discretion of the clinician 16. Overseas travel planned in follow up period of the study visits 17. Natural pneumococcal colonisation at baseline It is anticipated that 10-15% of screened participants will have natural pneumococcal colonisation at the time of recruitment as demonstrated by the initial nasal wash. These individuals will be excluded from the study after screening visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence of SPN3 pneumococcal bacteria in nasal wash recovered by classical microbiological culture at any timepoint post inoculation: Day 2, Day 7 or Day 14. This will be reported as yes or no. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Density of bacteria recovered from nasal wash by classical microbiological culture in positive participants, this will be reported as colony forming units (CFU) per ml of nasal wash. 2. The presence of SPN3 pneumococcal bacteria in nasal wash recovered by molecular methods at any timepoint post inoculation: Day 2, Day 7 or Day 14. This will be reported as yes or no. | — |
Countries
England, United Kingdom
Contacts
Public ContactRyan Robinson
Outcome results
None listed