Experimental human Pneumococcal carriage: Aging and immunity

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 74

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

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)