French biotech company Valneva is set to launch a Phase III clinical trial of its chikungunya vaccine called VLA1553.
Study initiation is dependent on the coronavirus (Covid-19) situation.
The news comes after the company had an end-of-Phase II meeting with the US Food and Drug Administration (FDA) and agreed on VLA1553’s clinical development plan.
According to Valneva, the Phase III study will have a double-blinded, placebo-controlled, multi-centre design and will recruit around 4,000 healthy volunteers.
Participants will receive the chikungunya vaccine or placebo. The primary endpoint will be the safety and immunogenicity of a single-shot VLA1553 vaccination at day 29.
The final review of the nine-month study will be scheduled for day 180.
Valneva chief medical officer Wolfgang Bender said: “We would like to thank the US FDA for a productive end of Phase II meeting. We look forward to further demonstrating the best-in-class potential of our single-shot chikungunya vaccine VLA1553 in our Phase III programme.
“Providing a vaccine against chikungunya is critical as the virus is considered a major public health threat and there are currently no preventive vaccines or effective treatments available. We are thrilled about the prospect to potentially have a vaccine available by the end of 2022.”
VLA1553 is a single-dose, monovalent, live-attenuated vaccine designed to deliver prophylactic, active immunisation against chikungunya virus in individuals aged above one year.
Phase III trial of the vaccine is expected to be initiated in the first quarter of this year.
Valneva noted that regulatory approval of the vaccine will be based on an immunological surrogate under an accelerated approval pathway.
Last November, Valneva reported positive data from the Phase I trial of VLA1553, which secured fast-track designation by the FDA in December 2018.