Valneva SE, a fully integrated commercial stage biotech company focused on developing innovative, lifesaving vaccines, 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 vaccine-induced viremia thereby indicating potential efficacy of VLA1553 early in clinical development.
First data from the trial are expected to be available early 2019.
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Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented “We are proud to contribute to the ongoing global efforts to develop effective prevention against the increasing threat to public health caused by the Chikungunya virus. We have developed a sophisticated Phase I design with the intent to provide us with an early indication of competitive advantage that we anticipate for our vaccine candidate.“
VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate for protection against Chikungunya. It is designed for prophylactic, active, single-dose immunization against Chikungunya in humans over one year old.