Jan 07, 2020: Valneva SE announced that the End Of Phase 2 (EOP2) meeting has been scheduled with the U.S. FDA on February 24, 2020 for its single-shot chikungunya vaccine candidate, VLA1553.
This plans will be presented for Phase 3 clinical studies and licensure. VLA1553 has been awarded Fast Track designation by the FDA and may be eligible for a Priority Review Voucher.In November 2019, Valneva reported final Phase 1 results confirming VLA1553’s outstanding immunogenicity and safety profile, also completed all required non-clinical studies requested by the FDA.
Phase 1 Clinical Study VLA1553-101 was a randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553, administered as a single immunization.
It enrolled 120 healthy volunteers, 18 to 45 years of age, in the United States. Subjects were randomized into three different study groups to accept one of three dose levels (30 subjects in the low and medium and 60 subjects in the high dose group).
The protocol includes a re-vaccination with the live-attenuated vaccine candidate VLA1553 at Month 6 (for 30 subjects in the high dose group) or Month 12 (for all others) to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from vaccine-induced viremia (intrinsic viral challenge).
Study participants were followed until 13 months after initial vaccination. An independent Drug Safety Monitoring Board (DSMB) continuously oversaw the study and reviewed safety data.
Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (NCT03382964).Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by the Aedes mosquitoes.
Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash, potentially developing into long-term, serious health impairments https://fda.einnews.com/pr_news/506572181/valneva-announces-end-of-phase-2-meeting-with-the-fda-for-its-chikungunya-vaccine-candidate