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Adrian Wildfire is project director, Infectious Diseases &Viral Challenge Unit, SGS Life SciencesâClinical Research.
Challenge trials may increase in coming years as new and improved challenge agents better emulate “natural” disease states.
A human challenge study offers several advantages when testing drugs or vaccinations for infectious diseases, because proof of efficacy can be measured in humans across a defined period of infection as the exact time at which exposure to the infectious agent is known. Usually this knowledge as to when infection takes place is unknown, and therefore it is also undeterminable as to where on the disease cycle the subject is. Sampling events are scheduled to take specimens at critical periods, and symptomology is carefully monitored throughout.
Pharmaceutical Technology and BioPharm International
eBook: Vaccine Development and Manufacturing 2017
When referring to this article, please cite it as A. Wildfire, "Using Human Challenge Trials to Develop Flu Vaccines," Pharmaceutical Technology and BioPharm International Vaccine Development and Manufacturing 2017 eBook (November 2017).