Valneva Completes Recruitment for Phase 3 Lot-to-Lot Consistency Trial of its Chikungunya Vaccine Candidate
Saint Herblain (France), June 10, 2021 – Valneva SE (“Valneva” or “the Company”), 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 20211. 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) 2.
VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 20324.
To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing and marketing of VLA1553. The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI) signed in July 2019, which provides funding of up to $23.4 million.
About Phase 3 study VLA1553-302
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1 Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial
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