Nasopharyngeal colonisation by pneumococcus Infections and Infestations
Conditions
Interventions
Nasal exposure with Streptococcus pneumoniae SPN6B. Participants will undergo exhaled assessment via the BreathSpec and 'exhaled detection facemask' pre- and post pneumococcal inoculation. Samples wil
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 years 2. Fluent spoken English 3. Access to mobile telephone – to ensure safety and timely communication 4. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Research participant: 1.1. Currently involved in another study unless observational or non-interventional except for the EHPC bronchoscopy study 1.2. Participant in a previous EHPC trial within the last 3 years (at the discretion of the study team, i.e. not inoculated nasally with pneumococcus) 2. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in UK babies born since 2005 or US 2001) 3. Allergy: to penicillin/amoxicillin and clarithromycin (or other macrolides) 4. Health history: 4.1. Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease 4.2. Medication that may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane) or disease-modifying anti-rheumatoid drugs. 4.3. Recent antibiotics (within the last 28 days or long term for known active chronic infection) 4.4. Current illness or acute illness within 14 days prior to inoculation 4.5. Major pneumococcal illness requiring hospitalisation 4.6. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study 5. Direct caring role or close contact: with individuals at higher risk of infection: 5.1. Children under 5 years age 5.2. Chronic ill health or immunosuppressed adults 6. Smoker: 6.1. Current or ex-smoker (regular cigarettes, regular e-cigarette/vaping and regular smoking of recreational drugs) in the last 6 months 6.2. Previous significant smoking history - more than 20 cigarettes per day for 20 years or the equivalent (>20 pack years) 7. Women of childbearing potential (WOCBP): who are: 7.1. Not deemed to have sufficient/effective birth control or confirmed abstinence 7.2. Pregnant 8. 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 the discretion of the clinician 9. Overseas travel planned in the follow-up period of the study visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exhaled biomarker analysis performed by BreathSpec post-inoculation at D0+4, D2, D7, D14, then D14+4, D15, D16, D21 post booster inoculation | — |
Secondary
| Measure | Time frame |
|---|---|
| BreathSpec: 1. The density and duration of pneumococcal colonisation as defined by nasal wash and BreathSpec post-inoculation at D0+4, D2, D7, D14, then D14+4, D15, D16, D21 post booster inoculation Exhaled Detection Facemask: 1. The rate of pneumococcal bacterial shedding as defined by exhaled detection facemask and cough-plate based assessment post- inoculation at D2, D7, D16, D21 (presence and density (CFU/ml) 2. Pneumococcal carriage density as defined by the exhaled detection facemask and cough-plate based assessment post-inoculation at D2, D7, D16 and D21 | — |
Countries
England, United Kingdom
Outcome results
None listed