Specialty vaccine company Valneva has initiated a Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553.
VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials. Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV). Infection leads to symptomatic disease in 72-92 percent of humans after 4 to 7 days following the mosquito bite. There have been more than 3 million reported cases of the disease in the Americas.
The objective of this study is to show the manufacturing consistency of the vaccine. It will attempt to do that by demonstrating that three consecutively manufactured lots elicit equivalent immune responses measured by neutralizing antibody titers on Day 29 after vaccination.
“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,” Juan Carlos Jaramillo, chief medical officer of Valneva, said.
VLA1553 is a live-attenuated, single-dose vaccine candidate. The sponsor of the first chikungunya vaccine Biologics License Application to be approved in the U.S. will be eligible to receive a Priority Review Voucher.