RSV Human Challenge Study as a tool for a break-through designation

An international biotech company, headquartered in the EU approached hVIVO to explore the possibility of performing a RSV Phase IIa challenge study. The investigational product was a novel recombinant modified vaccinia virus Ankara RSV vaccine candidate. The company wanted to obtain proof of efficacy and additional safety data by Dec-21, (building on data from their initial “In-Human” study) before launching a global Phase III programme.