Valneva宣布了为期六个月的抗体持久性和II期临床试验的安全性数据，评估两种不同剂量水平的单次注射基孔肯雅疫苗（IXCHIQ）在304名儿童中的安全性和免疫原性

• IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV)
   
• Antibody levels remained high after six months in both dose groups, although more robust with the full dose
   
• Six-month data confirm full dose selection for pivotal Phase 3 trial

Saint-Herblain (France), June 5, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group.

Trial VLA1553-221's six-month results were in line with the initial data the Company reported for this trial in January 20251. A full dose (licensed IXCHIQ® formulation and presentation) elicited a more robust immune response in children aged one to eleven years at Day 15 and Day 180 post vaccination compared to a half dose. Overall, the immunological response profile was in line with what was previously observed in adults and adolescents234567.

The strong immune response was confirmed in CHIKV-naïve children with a 96.5% seroresponse rate (full dose) at Day 180. VLA1553 was well tolerated in children aged one to eleven years regardless of the dose or previous CHIKV infection. No safety concerns were identified.

The comparability of the VLA1553 doses tested in terms of safety and tolerability, along with the more pronounced immune response of the full dose observed for all age groups tested in children up to Day 180 post-vaccination, support the selection of the full dose for use in this population.