Valneva announced that it has completed recruitment for the clinical lot-to-lot consistency Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.
The company — based in Saint Herblain, France — said 410 participants 18-45 years old have been randomized in the Phase 3 trial VLA1553-302 and will be followed for a total of six months. The objective of the trial 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.
The company says that VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials at this time.
The lot-to-lot consistency Phase 3 trial runs in parallel to the ongoing, pivotal Phase 3 trial, VLA1553-301, for which the company already has recruited participants.
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, rash, and chronic arthralgia.
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 high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia.
VLA1553 is a live-attenuated, single dose vaccine candidate for protection against the chikungunya, which has spread to more than 100 countries. It has been designed by deleting a part of the chikungunya virus genome.
The program was granted Fast Track designation by the FDA in December 2018 and PRIME designation by the European Medicines Agency (EMA) in October 2020.
