The Effect of Live Attenuated Influenza Vaccine (LAIV) on Experimental Human Pneumococcal Colonisation (EHPC) Study

Phase 1

• Conditions: Pneumococcal colonisation post inoculation; MedDRA version: 18.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2014-004634-26-GB
• Lead Sponsor: Royal Liverpool University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-28
• Study Completion: 2017-04-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 335

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified