LAIV PROTECT CORRELATES Study
Research type
Research Study
Full title
Immune correlates of protection induced by Live Attenuated Influenza Vaccine (LAIV or Fluenz Tetra)
IRAS ID
187603
Contact name
Ajit Lalvani
Contact email
Sponsor organisation
Imperial College London
Eudract number
2015-002833-23
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Respiratory infections are among the top five causes of death globally and influenza virus infections contribute substantially to this burden of mortality. Influenza infects on average 10 – 20% of the population in any season and the disease spectrum ranges from asymptomatic infection, through cold-like illness, to serious respiratory illness requiring medical attention or hospitalisation and even death.
Vaccines are the most effective tool in preventing infection and transmission of influenza. In the UK, influenza vaccination is recommended for high risk groups. In July 2012, the UK's Joint Committee on Vaccines and Immunisation (JCVI) recommended the introduction of vaccination for all children aged 2-16 years against flu using live attenuated influenza vaccine (LAIV). The roll out of LAIV vaccination was initiated by Public Health England in 2013.
Despite data supporting the effectiveness of LAIV, less is known about the type of immune responses induced by vaccination that provide this protection. Published work has suggested potential roles for a number of immune responses in protecting against influenza in natural infection in adults. However, whether LAIV induces similar protective immune responses in children is not known.
The national roll out of LAIV vaccination provides a unique opportunity to study the protective immunology, efficacy and safety of LAIV in a community of UK school children. The study will determine
- whether LAIV induces immune responses proposed to be protective against infection,
- will examine the effect of previous exposure to influenza infection or vaccination on the immune response to LAIV
- will use gene expression profiling to search for novel candidate biomarkers that indicate protection resulting from vaccination.REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0137
Date of REC Opinion
9 Sep 2015
REC opinion
Further Information Favourable Opinion