Experimental Human Pneumococcal Carriage Model Testing New Strains

Not Applicable

Completed

• Conditions: Specialty: Infectious diseases and microbiology, Primary sub-specialty: Antimicrobial Research; Infections and Infestations; Infection/ Bacterial, viral and other infectious agents; UKCRC code/ Disease: Infection/ Bacterial, viral and other infectious agents

• Registration Number: ISRCTN68323432
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-15
• Study Completion: 2018-07-31
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 134

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)

Exclusion Criteria

1. Previous pneumococcal vaccination
2. History of pneumococcal illness
3. Close physical contact with at risk individuals (children under 5yrs, immunosuppressed adults, elderly, chronic ill health) -to minimise risk of pneumococcal transmission
4. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection
5. Allergy to penicillin/amoxicillin
6. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics. Also medication that may reduce immunity eg. Roacutanne
7. Current illness, acute illness within 3 days prior to inoculation or antibiotic treatment within 2 weeks of inoculation
8. Pregnancy - minimise risk of pneumococcal disease
9. Diagnosed as diabetic
10. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
11. Have been involved in a clinical trial involving EHPC and bacterial inoculation
12. History of drug or alcohol abuse
13. Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease
14. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease
15. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease
16. Unable to give fully informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inoculated pneumococci is assessed using classical culture methods at any time point from nasal wash recovered from the participants at days 2, 7 and 14 following first pneumococcal challenge.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Factors local to the nasal mucosa which determine the probability or intensity of colonisation (levels of inflammation as measure by cytokines and cellular infiltration measure by flow cytometry) are measured using the nasal cells at days two, seven and 14 following first pneumococcal challenge.<br> 2. Protective effect of carriage against the reacquisition of carriage following inoculation with a different pneumococcal strain to be evaluated after the repeat study on days two and seven following second pneumococcal inoculation.<br>