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.