Valneva SE, a commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced progress in its Phase 1 program targeting a single-shot vaccine against Chikungunya. 

Image/CDC
Image/CDC

The Company has now commenced the second stage of its Phase 1 study. A first group of study participants is now being re-vaccinated. This re-vaccination will act as an intrinsic human challenge, with the goal of demonstrating that subjects are protected from vaccine- induced viremia early in the VLA1553 clinical development.

Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented, “Our Phase 1 trial is progressing well and we are excited to commence the re-vaccination stage. We are strongly committed to use our expertise in vector-borne diseases to find a vaccine solution against this continuing public threat.” 

VLA1553’s Phase 1 clinical trial is a randomized, observer-blinded, dose-escalation, multi- center study. It is investigating three different dose levels of VLA1553 in approximately 120 healthy adults vaccinated with a single-shot immunization. Valneva announced at the beginning of August that it had completed enrollment for the trial. The Company now expects to announce initial data in early 2019. 

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. The vaccine aims for long-lasting protection and an anticipated safety profile similar to licensed vaccines for active immunization in adults and children. The target population segments are travelers, military personnel and individuals at risk living in endemic regions.