Specialty vaccine company Valneva SE has concluded recruitment of 4,131 adults for a phase three trial of VLA1553, a single-shot chikungunya vaccine candidate.
If approved, VLA1553 would be the first chikungunya vaccine to gain Biologics License Application. This would, in turn, earn its sponsor a Priority Review Voucher and will support licensure.
“We are extremely pleased to have reached this important milestone despite the ongoing COVID-19 pandemic affecting many people worldwide and creating challenges for recruitment into clinical trials,” Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said. “Chikungunya virus is a major, growing public health threat, and we are looking forward to our top line data in mid-2021. We would like to thank everyone involved, we could not have achieved this important milestone without hard work and dedication”.
The phase three trial first began in September 2020. It will be placebo-controlled and double-blinded, focusing on demonstrating both the safety and immunogenicity of the vaccine 28 days after a single shot. A subset of patients will be tested for sero-protection based on an immunological surrogate. A separate antibody persistence trial will follow that subset for a period of five years.
While the focus is on the 28-day mark, those participating in the main trial will be studied for six months.