EUCTR2014-004634-26-GBActive, not recruitingPhase 1
The Effect of Live Attenuated Influenza Vaccine (LAIV) on Experimental Human Pneumococcal Colonisation (EHPC) Study - LAIV and EHPC
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 335
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •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
Investigators
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