Influenza Challenge Model Clinical Research

COSTA MESA, Calif./IReach–PRNewswire/–WCCT Global, a full-service CRO headquartered in Orange County, CA, presented the results of a recent clinical study which will make use of the influenza challenge model, a unique proof of concept study design for evaluating potential new vaccines or therapeutics which is dependent upon identifying individuals who lack immunity to the “challenge strain.” The influenza challenge model, also known as the viral challenge model, is an alternative approach to field studies in influenza clinical research, which require that participants currently suffer from the virus, making it more difficult to identify potential subjects for participation in research. WCCT Global presented the results of this program at the OPTIONS IX for the Control of Influenza in Chicago, IL on August 26. The conference is being hosted by the International Society for Influenza and other Respiratory Virus Diseases.

At WCCT Global’s commercial US-Based Influenza Challenge Facility, a Controlled Quarantine Environment with 30 private rooms with multiple lab processing areas and PBMC harvesting and preservation capabilities, volunteers throughout Southern California were recruited as a part of prescreening for an H1N1 Influenza challenge model study. Serum samples from all volunteers were assayed for hemagglutination inhibition (HAI) titers to A/California/7/2009 (H1N1). Of the tested population, 22.0% had HAI titer levels less than 1:40. Between the months of March and June in 2016, nearly 1,000 volunteers ranging in age from 18 to 56 and of diverse ethnic backgrounds were evaluated at WCCT’s facility.

The results of the program demonstrated that the lack of detectable HAI titers in 22% of our population indicates there is still a significant portion of the population who would be susceptible to an H1N1 outbreak and also be eligible to enroll in an influenza challenge model study. Seroprevelence rate of 22% has dropped from 32% in 2015 reflecting the spread of H1N1 in California in the 2015-2016 season. Dr. Dave McIlwain, had this to say regarding the significance of WCCT’s findings: “These results demonstrate the continued need for research in treating influenza, as a large portion of the population is still at risk for an outbreak. By utilizing the influenza challenge model, we remove various obstacles that are typically present when conducting field studies and is able to produce data that is equally, if not more valuable.” WCCT looks forward to continuing their contributions to influenza clinical research, and the development of other vaccines, through the use of the viral challenge model in the near future.