Valneva has started its Phase I clinical study to evaluate the safety and immunogenicity of VLA1553 in Chikungunya, a mosquito-borne viral disease caused by the Chikungunya virus (CHIKV).
The randomised trial will be conducted in the US and will examine three different dose levels of VLA1553. Around 120 healthy adults will be vaccinated with a single-shot immunisation.
Antibody persistence and an additional vaccination will also be evaluated, using the highest dose of VLA1553 at six and 12 months.
The re-vaccination is expected to work as an intrinsic human viral challenge, attempting to show that subjects are protected from vaccine-induced viremia and indicating the potential efficacy of VLA1553 early in clinical development.
Initial data from the study are scheduled to be available early next year.
Valneva chief medical officer Wolfgang Bender said: “We have developed a sophisticated Phase I design with the intent to provide us with an early indication of competitive advantage that we anticipate for our vaccine candidate.”
VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate designed to protect against Chikungunya in humans over one year old.
Researchers hope the vaccine will provide long-lasting protection and safety for active immunisation in adults and children, similar to licensed vaccines.
Chikungunya is transmitted by Aedes mosquitoes and its clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headaches and nausea. The symptoms have the potential to develop into long-term, serious health impairments.
The disease is reported to cause clinical illness in 72%-92% of infected humans around four to seven days after an infected mosquito bite.