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news.WCCT Global, a full Service Contract Research Organization headquartered in Southern California announced their involvement in a sentinel clinical trial designed to evaluate safety and immunogenicity signals from a novel oral vaccine for influenza, as opposed to injectable or intranasal vaccines.
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The study was first presented to the scientific community on October 14, 2014 at the World Vaccine Congress in Brussels, Belgium by Vaxart.
WCCT Global conducted this phase I clinical trial where 24 healthy volunteers were enrolled who received either the active oral vaccine or a placebo. WCCT Global was chosen to run this trial because of their vast experience in phase I clinical trials and their known expertise in influenza research.
This full service CRO was crucial to the success of the trial because the study called for volunteers that had undetectable antibody titers to influenza to qualify for participation. This resulted in an extremely high screen failure rate but WCCT Global’s ability to screen large numbers of volunteers enabled the CRO to find and enroll the needed volunteers in a timely manner.
Furthermore, WCCT Global is the only CRO with a dedicated influenza challenge unit in the United States. Therefore, they are in a unique position to support the anti-viral and influenza vaccine Pharma sponsors for their first-in-man safety testing and immediately follow with an influenza challenge proof of concept study.
This WCCT Global’s capability to recruit, enroll and maintain the best volunteers/patients for the trial has enabled this CRO to also succeed in Phase II and III clinical research.
Jon Rojas, WCCT Global’s Chief Operating Officer stated, "We have established WCCT Global’s clinical sites in densly populated locations to screen high concentrations of volunteers to ensure enrollment and expert scientific support toallows clients the best solution for their clinical trial no matter the phase."