Valneva has completed the lot-to-lot Phase III consistency trial of VLA1553, its single-dose investigational vaccine candidate for chikungunya, a mosquito-borne viral disease.
The live-attenuated vaccine candidate has been designed by deleting a portion of the chikungunya virus genome.
With six-month follow-up data included, the final analysis confirmed the topline results that were reported last December.
The Phase III trial VLA1553-302, which included 408 participants aged 18 to 45 years, met its primary endpoint.
It showed that three vaccine lots that were consecutively manufactured, elicited equivalent immune responses measured by neutralising antibody titer GMT ratios on Day 29 following vaccination.
In the clinical lot-to-lot prospective, multicentre, randomised, pivotal study, lyophilized VLA1553 were administered as a single intramuscular immunisation.
Assessment of a pair-wise comparison of the 95% Confidence Interval (CI) on the ratio of GMTs on Day 29 after vaccination in the three vaccine lots, was the study’s primary objective.
After vaccination, participants in the trial were followed for a period of six months.
Furthermore, the safety profile shown in study VLA1553-302 was similar to the Phase III VLA1553-301 trial.
Valneva chief medical officer Juan Carlos Jaramillo said: “We are extremely pleased that the final lot-to lot data confirmed the previously reported topline results. We have now all necessary clinical data to support submission with the US Food and Drug Administration (FDA), which we plan to start later this year.
“We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
Last July, the FDA granted Breakthrough Therapy Designation to Valneva’s chikungunya programme.
In October last year, Valneva reported that its Covid-19 vaccine candidate, VLA2001, met the co-primary goals of the Phase III Cov-Compare clinical trial in adolescent and adult subjects.