Influenza Clinical Trial
Official title:
A Randomised, Double Blind Study To Characterise Influenza A/Perth/16/2009(H3N2) Virus
The study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants
using the viral challenge model. The study includes two cohorts.
Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the
optimum titre.
Cohort 2: An open-label extension arm in which all participants will receive the 'optimum'
titre as identified from Cohort 1.
Influenza and its associated diseases are a major cause of morbidity and mortality. The
United States Advisory Committee on Immunization Practices recommends influenza vaccination
for everyone over 6 months of age. The failure of the flu vaccine in 2014-2015 demonstrates
the need for a model that allows the rapid development of novel antivirals,
universal/intra-seasonal vaccines, immunomodulators, monoclonal antibodies and other novel
treatments. Studies using experimental influenza virus infection in human participants have
demonstrated that adult volunteers can be infected by nasal inoculation, and experimental
infection is safe and not associated with transmission to contacts. The experimental virus is
manufactured in compliance with Good Manufacturing Practice for use in the Human Viral
Challenge Model.
The investigators chose an H3N2 influenza subtype given that this strain has the most
substantial impact in terms of morbidity or mortality annually as described by the Centre for
Disease Control . The investigators first subjected the virus batch to rigorous adventitious
agent testing, then confirmed the virus to be wild-type by Sanger sequencing and finally
determined the virus titres appropriate for human use via the established ferret model. hVIVO
team built on its previous experience with other H3N2 and H1N1 viruses to develop this unique
model.
The first part of study (Cohort 1) was to determine the safety and optimal virus titre in
healthy adult volunteers using our unique clinical quarantine facility in London, UK. After
the first part of the study was completed, the study was amended to add an older population
group (45-64 years old) in order to characterise the course of infection in an age group
better representing the at-risk population.
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