Valneva, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the clinical lot-to-lot consistency Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials at this time.
410 participants aged 18 to 45 years have been randomized in the Phase 3 trial VLA1553-302 and will be followed for a total of six months. The objective of the trial 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.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “We are pleased to have reached this new recruitment milestone. We’ve now enrolled all participants for both our pivotal Phase 3 trial and lot-to-lot consistency trial so our VLA1553 program is progressing extremely well. Chikungunya virus is a major, growing public health threat and we are looking forward to our top line data this summer”.
The lot-to-lot consistency Phase 3 trial runs in parallel to the ongoing, pivotal Phase 3 trial, VLA1553-301, for which the Company already announced recruitment completion in April 2021. 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).