Vaccine company, Valneva, announced that it has completed recruitment for the pivotal Phase 3 trial, VLA1553-301, of its single-shot chikungunya vaccine candidate, VLA1553.
The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).
The primary endpoint of the double-blinded, placebo-controlled study is to demonstrate safety and immunogenicity 28 days after a single-shot vaccination with VLA1553 including a subset of participants (immunogenicity subset) tested for sero-protection based on an immunological surrogate agreed with the Food and Drug Administration (FDA). Participants will be followed for six months in the pivotal trial. On April 1st 2021, Valneva also initiated an antibody persistence trial, VLA1553-303, that will follow the immunogenicity subset for a period of five years.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are extremely pleased to have reached this important milestone despite the ongoing COVID-19 pandemic affecting many people worldwide and creating challenges for recruitment into clinical trials. Chikungunya virus is a major, growing public health threat and we are looking forward to our top line data in mid-2021. We would like to thank everyone involved, we could not have achieved this important milestone without hard work and dedication”.
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