Valneva Successfully Completes Pivotal Phase 3 Trial Of Chikungunya Vaccine Candidate

(RTTNews) - Valneva SE (VALN), said on Tuesday that it has successfully completed the phase III pivotal trial of its single-shot Chikungunya vaccine candidate VLA1553.

With the successful completion of six-month follow-up that met all the end points, the French biotech firm now expects to start the pre-submission process for VLA1553 with the FDA in the second quarter.

The final analysis of the phase III trial, dubbed VLA1553-301, has confirmed the very high level of seroprotection, with 98.9% of participants achieving protective levels of chikungunya virus neutralizing antibodies one month after receiving a single vaccination of VLA1553. Similarly, after six months of receiving a single vaccination of VLA1553, 96.3% of participants showed protective levels of chikungunya virus neutralizing antibodies, the company added.

The six-month safety and tolerability profile of VLA1553 has also been found to be consistent with previous results.

Valneva's Chikungunya vaccine initiative was awarded Breakthrough Therapy Designation by the FDA in July 2021.