Valneva's Chikungunya Vaccine Advances With Pediatric Trial, Phase 3 In 2026

Valneva SE (NASDAQ:VALN) on Thursday announced six-month antibody persistence and safety data for its Phase 2 trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, Ixchiq, in 304 children, according to a press release.

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.

The objective is to extend the product label to this age group.

Also Read: US Health Agencies Recommend Pausing Valneva’s Chikungunya Vaccine For Older Adults After Adverse Events

Trial VLA1553-221’s six-month results were in line with the initial data the company reported for this trial in January 2025.

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 adolescents.

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 11 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.

Juan Carlos Jaramillo, chief medical officer of Valneva, said, “The six months persistence and safety data in children are aligned with the robust antibody response and safety profile we reported in adolescents after a single vaccination.”

In April, the Brazilian Health Regulatory Agency (ANVISA) granted marketing authorization to Valneva’s Ixchiq to prevent disease caused by the chikungunya virus in individuals 18 and older.

The ANVISA decision marks the world's first approval of a chikungunya vaccine in an endemic country.

VALN Price Action: VALN stock is up 0.49% at $6.28 at publication on Thursday.

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