CRO WCCT Global, headquartered in Southern California, is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for influenza challenge research. With the construction of WCCT Global's influenza challenge facility in Costa Mesa, Calif., the CRO has the capability to conduct virus challenge clinical trials in North America.
Mel Affrime, WCCT Global's senior vice president, translational medicine, said, "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."
Despite their utility, human challenge studies with influenza in healthy volunteers have not been performed in over a decade in the U.S. 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.
The Clinical Studies Unit of the Viral Pathogenesis and Evolution Section of the Laboratory of Infectious Disease in NIAID is a research group that develops clinical and translational studies of influenza and other respiratory viruses with particular attention to human influenza pathogenesis. The development of influenza challenge viruses and overall models to study human disease are a primary focus with great attention to informing novel vaccine and therapeutic development. This group is part of a larger section of respiratory viral research that includes studies of animal models, viral evolution, host response and viral adaptation.