Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced that it has initiated the clinical lot-to-lot consistency Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553.
This study will run in parallel to the ongoing, pivotal Phase 3 study, VLA1553-301, which includes the determination of seroprotection based on an immunological surrogate.
The objective of this study is to show manufacturing consistency of the vaccine by demonstrating that three consecutively manufactured lots elicit equivalent immune responses measured by neutralizing antibody titers on Day 29 after vaccination. Study volunteers will be followed for a total of six months.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This study initiation signifies another important step in the development of VLA1553 towards licensure. The chikungunya virus continues to represent a major public health threat, and we are working as fast as we can to bring a preventive solution to those who need it most. We would like to thank our employees, partners and study participants for making this trial possible despite the ongoing COVID-19 pandemic.”
VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials. 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).