Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), February 22, 2021 – Valneva SE (“Valneva” or “the Company”), 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 surrogate1.
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)2.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash. 4.1%-78.6% of infections develop into chronic arthralgia (> 3 months). Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The highest risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there have been more than 3 million reported cases in the Americas3 and the economic impact is considered to be significant (e.g. Colombia outbreak 2014: $73.6 million4). The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to further spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.