Valneva SE (NASDAQ: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.
