Characterisation of a wild-type influenza (A/H1N1) virus strain as an experimental challenge agent in humans.

ABSTRACT:

Background

Human challenge models using respiratory viruses such as influenza are increasingly utilised in the development of novel vaccines and anti-viral modalities and can provide preliminary evidence of protection before evaluation in field trials. We describe the results of a clinical study characterising an A/H1N1 influenza challenge virus in humans.

Methods

The challenge agent, influenza A/California/2009 (H1N1), was manufactured under cGMP conditions and characterised in accordance with regulatory guidelines. A dose-ascending open-label clinical study was conducted in 29 healthy young adults screened sero-negative to the challenge strain. Subjects were intranasally inoculated with three increasing doses of virus and physician-reported signs, subjected-reported sympto

SUBMITTER: Watson JM 

PROVIDER: S-EPMC4322439 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature