The effect of live attenuated inactivated influenza vaccine on experimental human pneumococcal carriage study

Not Applicable

Completed

• Conditions: Topic: Infectious diseases and microbiology; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN16993271
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-04
• Study Completion: 2017-11-14
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

Participants will be eligible to participate in this study provided they:
1. Have capacity to give informed consent
2. Aged 18-50 yrs - ages chosen to minimise the risk of pneumococcal infection
3. Speak fluent English to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximise participant safety

Exclusion Criteria

1. Currently involved in another study unless observational or in follow-up phase (noninterventional)
2. Received any influenza vaccine in the last 2 years
3. Egg allergy (as per influenza vaccines patient leaflet)
4. Previous significant adverse reaction to any vaccination/immunisation
5. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission and transmission of virus for those receiving the LAIV
6. Current regular smoker (smokes daily)
7. Significant smoking history [defined as someone who has previously smoked more than 20 cigarettes per day for 10 years or the equivalent (>10 pack yrs)] – to minimise risk of bronchoscopy or pneumococcal disease
8. Asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal disease
9. Pregnant to minimise the risk of pneumococcal disease
10. Women of childbearing potential (WOCBP) who are not deemed to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination
11. Allergic to penicillin/amoxicillin/ gentamicin
12. On medication that may affect the immune system in any way e.g. steroids, steroid nasal spray
13. Are regularly taking acetylsalicylic acid (aspirin) – as per LAIV guidance to reduce the risk of Reye’s syndrome
14. Been involved in a clinical trial involving EHPC over the last 3 years
15. Unable to give fully informed consent
16. Current acute severe febrile illness - to avoid vaccination and inoculation in participants that may have current infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. We will define the effect of LAIV on pneumococcal colonisation using the EHPC model in order to assess the potential effects of mass influenza vaccination. We will measure colonisation acquisition, density and duration.<br> 2. Pneumococcal colonisation will be monitored using microbiological cultures of nasal wash samples. Nasal wash samples will be taken at pre-vaccination/ preinoculation*, day 2, 6*/7, 9, 14, 21*/22 and 27*/29 post inoculation in study one and study two*.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. To evaluate changes in commensal and potential pathogenic species in nasopharyngeal microbiome associated with influenza vaccination<br> 2. To evaluate inflammatory responses at the nasal mucosa using mucosal nanosampling method (lining fluid and cells)<br> 3. To evaluate cellular responses in the lung after LAIV and EHPC co-infection<br> 4. To evaluate symptoms associated with influenza vaccination and EHPC<br>