Valneva Kickstarts Phase 3 Trial Of Chikungunya Vaccine Candidate In Adolescents

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Valneva SE VALN has initiated a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553.

  • The collaboration falls within the framework of the agreement signed between Coalition for Epidemic Preparedness Innovations and Valneva in July 2019, which provides funding of up to $23.4 million with support from the European Union's Horizon 2020 program.
  • It is also expected to support the vaccine's licensure in Brazil, the first potential approval for use in endemic populations.
  • Related: Valneva Posts Positive Lot-to-Lot Consistency Data For Its Single-Dose Chikungunya Vaccine.
  • The Phase 3 trial, dubbed VLA1553-321, will enroll 750 adolescents aged 12 to 17 years.
  • The trial's primary objective is to evaluate safety and immunogenicity following a single vaccination with VLA1553. 
  • Participants will be evaluated after 28 days and followed up to twelve months. 
  • The study will also provide safety and immunogenicity data in participants previously exposed to chikungunya.
  • In August 2021, Valneva reported topline results for the pivotal Phase 3 trial VLA1553-301 in adults aged 18 years and above. 
  • VLA1553-301 will continue towards the final analysis, including the 6-month safety data. The Company expects to report final trial results in early 2022.
  • The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032.
  • Price Action: VALN shares closed at $34.07 on Monday.
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