Healthy volunteers Infections and Infestations
Conditions
Interventions
Nasal exposure with Streptococcus pneumoniae SPN6B. Randomised 1:1:1 to wash hands with water only: wash hands with Lifebuoy bar soap and water: no hand washing intervention before attempting to trans
Sponsors
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 3. Access to mobile telephone – to ensure safety and timely communication 4. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Previous pneumococcal vaccination 2. In a caring role or with intimate physical contact with at-risk individuals (children under 5yrs, immunosuppressed adults) during the period of pneumococcal colonisation 3. History of or current regular drug or alcohol abuse (frequently drinking alcohol: men and women should not regularly drink > 3-4 units/day and >2-3 units/day respectively) 4. Taking daily medications that may affect the immune system e.g. systemic steroids, systemic corticosteroids, antibiotics, or disease-modifying anti-rheumatoid drugs, roacutanne decision at the discretion of study doctors and PI 5. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history) 6. Having received any antibiotics in the preceding 4 weeks 7. History of culture-proven pneumococcal disease requiring hospital admission 8. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 9. Involved in a clinical trial involving EHPC and bacterial inoculation with SPN6B in the past three years (inoculation with other SPN strains may be included if >6months after inoculation) 10. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions 11. At the clinician’s discretion any unstable or poorly controlled co-morbidity 12. Taking medication that affects blood clotting (except aspirin and clopidogrel) e.g. warfarin or other oral or injectable anticoagulants 13. Have any uncontrolled medical/ surgical conditions such as but not restricted to: hypertension, mental health conditions, epilepsy, narcolepsy, chronic conditions requiring pain medication such as osteoarthritis, skin conditions, allergies, hay fever, and any other condition at the discretion of the PI. 14. Allergy to penicillin/amoxicillin AND clarithromycin (or other macrolides) 15. Concern of the study doctor about the participant’s health 16. Any acute dermatological illness or skin injury affecting the hands or face at the discretion of the study doctors and/or PI- confounding effects of topical medications and propensity to infection 17. Pregnancy - minimise risk of pneumococcal disease 18. History of Smoking 18.1 Current or ex-smoker (regular cigarettes: smokes daily/ smokes >5 cigarettes per week, e-cigarette/vaping and recreational drugs) in the last 6 months 18.2 Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease 18.3 Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of SPN6 pneumococcal bacteria by classical microbiological culture at any time point post exposure (day 2, day 6/7 or day 9/10). The presence of pneumococcal bacteria will be recorded as yes or no in the database and will be analysed according to the group allocation at the end of the study. We will also monitor density as a secondary outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The occurrence of 6B pneumococcal colonisation determined by the presence of pneumococcus in NW at each time point post exposure (days 2, 6/7 and 9/10), detected using classical microbiology. 2. The density of 6B pneumococcal colonisation in NW at each time point following pneumococcal exposure (days 2, 6/7 and 9/10), detected using classical microbiology. 3. The area under the curve of 6B pneumococcal colonisation density following pneumococcal exposure (days 2, 6/7 and 9/10), detected using classical microbiology. 4. The duration of 6B pneumococcal colonisation determined by the last NW following pneumococcal exposure in which 6B pneumococcus is detected using classical microbiology 5. The occurrence of 6B pneumococcal colonisation determined by the presence of pneumococcus in NW at any time point post exposure up to and including day 9/10, detected using qPCR. 6. Endpoints 1-4 detected using qPCR instead of classical microbiology methods. | — |
Countries
United Kingdom
Contacts
Public ContactHelen Hill
Outcome results
None listed