Pneumococcal colonisation post inoculation MedDRA version: 18.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Fluenz Tetra/ FluMist
Product Name: Live Attenuated Influenza Vaccine (LAIV) Fluenz Tetra/ FluMist
Pharmaceutical Form: Nasal spray, solution in single-dose
Sponsors
Royal Liverpool University Hospital
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: have capacity to give informed consent aged 18-50 yrs - ages chosen to minimise the risk of pneumococcal infection 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 314 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Not currently involved in another study unless observational or in follow-up phase (non-interventional) Not received any influenza vaccine over the last 2 years No egg allergy (as per influenza vaccines patient leaflet) No previous significant adverse reaction to any vaccination/immunisation No close contact with at risk individuals (children under 5years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission and transmission of virus for those receiving the LAIV Not current regular smoker (smokes daily) No 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 No asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal disease Not pregnant - to minimise the risk of pneumococcal disease Women of child-bearing 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 No allergic to penicillin/amoxicillin/gentamicin Not taking medication that may affect the immune system in any way e.g. steroids, steroid nasal spray Not regularly taking acetylsalicylic acid (aspirin) - as per LAIV guidance to reduce the risk of Reye’s syndrome Not been involved in a clinical trial involving experimental human pneumococcal carriage in the last 3 years Unable to give fully informed consent No current acute severe febrile illness - to avoid vaccination and inoculation in participants that may have current infection Not taking long term antibiotics eg. following splenectomy or sickle cell disease Not been clinically diagnosed with flu in the last 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: To evaluate changes in commensal and potential pathogenic species in nasopharyngeal microbiome associated with influenza vaccination. To evaluate inflammatory responses at the nasal mucosa using mucosal nanosampling method (lining fluid and cells). To evaluate cellular responses in the lung after LAIV and EHPC co-infection. To evaluate symptoms associated with influenza vaccination and EHPC. ;Primary end point(s): Pneumococcal bacteria (6B) detected in nasal wash post inoculation at any point post inoculation ; Timepoint(s) of evaluation of this end point: Study 1: Pneumococcal bacteria detected post inoculation day 2,7,9,14,22,29 Study 2: Pneumococcal bacteria detected post inoculation day 2,6,9,14,21,27 Experimental colonisation is defined as pneumococcal bacteria (6B) detected at ANY TIMEPOINT post inoculation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pneumococcal density and duration post inoculation ; Timepoint(s) of evaluation of this end point: Study 1: Pneumococcal bacteria detected post inoculation day 2,7,9,14,22,29 Study 2: Pneumococcal bacteria detected post inoculation day 2,6,9,14,21,27 | — |
Countries
United Kingdom
Contacts
Public ContactAngela Wright
Royal Liverpool University Hospital
Outcome results
None listed