Specialty: Ageing, Primary sub-specialty: Ageing
Conditions
Interventions
Initial safety pre-screening will comprise a clinical assessment and examination by a physician, spirometry, electrocardiography and basic blood tests (blood count and kidney function).
If no issue i
Sponsors
Liverpool School of Tropical Medicine
Royal Liverpool & Broadgreen University Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (male or female) aged 50-84 years 2. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 3. World Health Organisation performance status 0 (able to carry out all normal activity without restriction) or 1 (restricted in strenuous activity but ambulatory and able to carry out light work) 4. Access to telephone (safety and timely communication) 5. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Close physical contact with at risk individuals (children under 5yrs, immunosuppressed adults) - minimise risk of pneumococcal transmission 2. History of drug or alcohol abuse (frequently drinking over the recommended alcohol intake limit: men and women should not regularly drink > 3-4 units/day and >2-3 units/day respectively) – minimise risk of pneumococcal disease 3. Smoking any cigarettes currently or within the last six months - minimise risk of pneumococcal disease 4. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease 5. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection 6. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics, disease modifying anti-rheumatoid drugs 7. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history) 8. Having received any antibiotics in the preceding 28 days 9. Taking medication that affects blood clotting e.g. aspirin, clopidogrel, warfarin or other oral or injectable anticoagulants 10. History of culture-proven pneumococcal disease 11. Allergy to penicillin/amoxicillin 12. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 13. Have been involved in a clinical trial involving EHPC and bacterial inoculation in the past three years 14. Significant cardiorespiratory disease (excluding stable hypertension) 15. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions 16. Taking any medications except those on the “allowed list”:statins; antihypertensives in stable hypertension; antidepressants; bisphosphonates; treatment for benign prostatic hyperplasia; hormone replacement therapy; vitamin supplements (including multivitamins, iron); anti-acid medications; nicotine replacement therapy (NRT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of colonisation of S. pneumoniae by classical bacterial culture methods from one or more nasal wash sample in the first 14 days following initial pneumococcal challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration and density of pneumococcal carriage in elderly patients is assessed using classical bacterial culture methods during 29 days following initial pneumococcal challenge 2. Rates of EHPC among different age-groups within the older population are assessed using classical bacterial culture methods during 29 days following initial pneumococcal challenge 3. The protective effect of prior carriage against colonisation following rechallenge is assessed using classical bacterial culture methods up to one year following initial pneumococcal challenge 4. Whether nasopharyngeal sampling is more sensitive than oropharyngeal sampling is assessed using classical bacterial culture methods and molecular testing in the first 14 days following initial pneumococcal challenge 5. Population of immune/inflammatory cells in response to challenge and/or colonisation is assessed by flow cytometric analysis during 29 days following initial pneumococcal challenge 6. Presence of a systemic humoral immune response to nasopharyngeal carriage is assessed by measuring specific antibody levels in serum by ELISA during 29 days following initial pneumococcal challenge 7. Presence of a local humoral immune response to nasopharyngeal carriage is assessed by measuring specific antibody levels in nasal washings by ELISA during 29 days following initial pneumococcal challenge 8. Functional activity of antibodies is measured by opsonophagocytic killing assays during 29 days following initial pneumococcal challenge 9. Symptoms following pneumococcal challenge is measured in a study-specific symptom log during the first seven days following initial pneumococcal challenge 10. Changes in the nasopharyngeal microbiome of elderly subjects following EHPC are measured using a multiplex analysis during 29 days following initial pneumococcal challenge | — |
Countries
United Kingdom
Contacts
Public ContactHugh Adler
Outcome results
None listed