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All news Valneva Initiates Phase I Clinical Study to Evaluate Its SingleShot Vaccine Candidate against Chikungunya
Lyon (France), March 13, 2018 – Valneva SE, a fully integrated commercial stage biotech company focused on developing innovative, lifesaving vaccines, today announced the initiation of a Phase I clinical trial in the U.S. to evaluate the safety and immunogenicity of VLA1553, its live-attenuated vaccine candidate against Chikungunya.
The Phase I clinical trial is a randomized, observer-blinded, dose-escalation, multi-center study. It will investigate three different dose levels of VLA1553 in approximately 120 healthy adults vaccinated with a single-shot immunization. The trial design includes the investigation of antibody persistence and an additional vaccination using the highest dose of VLA1553 at 6 and 12 months. This re-vaccination will serve as an intrinsic human viral challenge, aiming to demonstrate that subjects are protected from vaccineinduced viremia thereby indicating potential efficacy of VLA1553 early in clinical development.
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