Because it’s an academic collaboration, neither side has any financial obligations, WCCT SVP, Translational Medicine, Mel Affrime told Outsourcing-Pharma.com. WCCT recently constructed a Clinical Pharmacology Unit in Costa Mesa, California, and now has the ability to conduct virus challenge clinical trials.
The human viral challenge model, which means researchers track healthy volunteers infected with the virus over the course of the illness, has become accepted as an alternative to traditional early stage trials to show the efficacy of antivirals and vaccines, according to WCCT.
“With the influenza challenge study it is absolutely known that the subject had the flu (because they had been inoculated) and therefore the course infection can be easily observed in response to the treatment. In a vaccine challenge trial, the vaccine is administered first followed by influenza inoculation,” Affrime said.
However, this collaboration with NIAID is unique because human flu challenge studies in healthy volunteers have not been performed in over a decade in the US due to complications and the lack of available viruses and expertise.
“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,” Affrime explained. “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.”
The trials with NIAD will involve Matthew Memoli, director, Clinical Studies Unit, Viral Pathogenesis and Evolution Section, who developed a validated human challenge model and is continuing to develop human models to characterize illness with other common forms of the influenza virus.
NIAID says it entered the collaboration to expand the challenge model beyond its clinical center and to serve the demands of the vaccine and pharma industries.
WCCT also claims to be the first US CRO capable of conducting flu challenge trials. And although the company says it will continue to participate in field trials, it can also provide the “Healthy Volunteer Flu-Challenge Option” for sponsors seeking to evaluate early vaccine or antiviral prototypes.
“Importantly, if the drug seems not to work in the influenza challenge it is a strong signal to the pharma firm that they probably should not invest further in the development of that compound,” Affrime told us.