Biotech company Valneva has reported further positive Phase I results for its chikungunya vaccine candidate, VLA1553.
VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate designed for prophylactic, active, single-dose immunisation against chikungunya in humans over one year old.
Considered to be a major public health threat, chikungunya is a mosquito-borne viral disease. It is caused by the chikungunya virus (CHIKV), which is transmitted by Aedes mosquitoes.
The observer-blinded, multicentre, dose-escalation study assessed three dose levels of VLA1553 after a single immunisation.
As part of the randomised study, 120 healthy volunteers between the age groups of 18 to 45 years were enrolled in the US and randomised in three different study groups.
VLA1553 was found to be safe in all dose groups, showing an ‘excellent immunogenicity profile’.
The trial found no adverse events reported up to month seven.
Valneva chief medical officer Wolfgang Bender said: “We are thrilled about these exciting results confirming that we have identified a highly immunogenic and safe final product candidate, which we now aim to progress into pivotal trials as quickly as possible.
“In addition and as hoped, the data indicate that vaccinated subjects are protected from chikungunyaviremia. This marks a very important milestone getting us a step closer to a highly competitively differentiated vaccine addressing a serious threat to public health.”
The company further noted that a subset of study subjects were re-vaccinated after six months, and no anamnestic response was observed.
In December last year, the US Food and Drug Administration (FDA) granted Fast Track designation for Valneva’s chikungunya vaccine candidate.