Pharma Focus America

Valneva's Chikungunya Vaccine Candidate Shows Encouraging Safety Results in Early Phase 3 Trial with Adolescents

Monday, August 28, 2023

Valneva SE, a company specializing in vaccine development, has shared promising results from the early Phase 3 safety evaluation of its chikungunya (CHIKV) vaccine candidate, VLA1553, in adolescents. The study, denoted as VLA1553-321, is being supported by the Coalition for Epidemic Preparedness Innovations (CEPI) in partnership with the Butantan Institute. The primary objective of this trial is to potentially expand the vaccine's usage to adolescents upon its approval for adults by the US Food and Drug Administration (FDA). Furthermore, if successful, this study could lead to the vaccine's authorization for use in Brazil, becoming the first such approval for an endemic population. The gathered safety data might also facilitate an application for marketing authorization with the European Medicines Agency (EMA) later in the current year.

Initial safety findings from the ongoing VLA1553-321 trial, conducted within an endemic region and involving participants who were previously infected with the chikungunya virus, have indicated that VLA1553 was generally well-tolerated and safe among adolescents aged 12 to 17, regardless of their prior virus exposure.

The trial enrolled 754 participants who received either VLA1553 or a placebo, and the safety data was collected over a 29-day period. An independent Data Safety Monitoring Board (DSMB) closely monitored the trial and did not identify any major concerns. The adverse events observed after administration of VLA1553 were mainly mild or moderate and typically resolved within three days. Importantly, the early data also suggested a positive safety profile in participants who were HIV-positive.

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, emphasized that the safety findings in adolescents and individuals with previous chikungunya virus exposure align with the safety profile previously observed in adults and the elderly. He highlighted the importance of addressing the chikungunya threat, particularly in regions where the virus is endemic.

Valneva had previously released conclusive data from a Phase 3 trial involving adults aged 18 and older, with positive results published in The Lancet. The company is currently awaiting a priority review by the FDA, and a request for marketing authorization has also been submitted to Health Canada.

Chikungunya is a viral disease transmitted by Aedes mosquitoes, characterized by symptoms such as high fever, joint pain, and muscle pain. The lack of an existing preventive vaccine or effective treatment underscores the necessity for a solution like VLA1553. If approved, VLA1553 could be a pivotal tool in addressing this unmet medical need.

VLA1553-321, a Phase 3 clinical trial involving 754 adolescents aged 12-17 years in Brazil, is aimed at assessing the immunogenicity and safety of a single dose of VLA1553. The secondary objectives of the trial include monitoring safety and immunogenicity over a 12-month period post-vaccination.

Chikungunya virus infection poses a significant public health threat, with a growing economic impact, emphasizing the urgency of developing a vaccine to mitigate its effects.

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