With the construction of WCCT Global’s influenza challenge facility in Costa Mesa, California, the CRO has the capability to conduct virus challenge clinical trials in North America.
WCCT Global’s Senior Vice President, Translational Medicine, Mel Affrime stated, "Experimental influenza virus infection in healthy volunteers provides an opportunity to describe the natural history of this self-limiting illness by watching the entire disease lifecycle as healthy subjects develop a mild-to-moderate course of influenza and then fully recover.
"Therefore, the observer can obtain high quality, longitudinal data from all phases (before, during and after) of the illness. Ultimately, the experimental influenza challenge model can be used in many ways to study influenza, including the efficacy of new therapies such as antiviral drugs and vaccines.
"Expansion of this type of model apply both to WCCT Global and the NIAID and serve as the basis for this Collaboration Agreement."
Despite their utility, human challenge studies with influenza in healthy volunteers have not been performed in over a decade in the United States due to the complicated nature of such studies and availability of the appropriate viruses and expertise. NIAID scientist, Dr. Matthew Memoli, director, Clinical Studies Unit, Viral Pathogenesis and Evolution Section, developed a validated A(H1N1)pdm09 human challenge model and is continuing to develop human models to characterize illness with other common forms of influenza virus.
These models set the standard for future challenge models to be developed and NIAID has entered into this collaboration to begin to expand the challenge model beyond the NIH Clinical Center to serve the growing demands of the vaccine and pharmaceutical industry.