Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confirming a strong and long-lasting antibody persistence across all age groups investigated. The three-year persistence data are also in line with positive twelve-month and two-year persistence data the Company reported in December 2022[1] and 2023[2], respectively.
Among the 278 healthy adults still enrolled in the trial, 96% maintained neutralizing antibody titers well above the seroresponse threshold three years after the single-dose vaccination. Persistence of antibodies in older adults (age 65+) in terms of geometric mean titers (GMTs) and seroresponse rates (SRRs) was comparable to younger adults (18-64 years of age). Hence, the primary endpoint was met.
Study VLA1553-303, which has received funding support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union’s (EU) Horizon Europe program, also collected long-term safety data by following any ongoing Adverse Event of Special Interest (AESI) from the preceding study and collecting new-onset Serious Adverse Events (SAEs). The latest analysis does not include a further safety evaluation since safety data collection was concluded at two years after vaccination according to the Clinical Trial Protocol. No safety concerns were reported or identified during the two-year follow-up and no AESI were ongoing at the time of participant enrollment in the trial.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are extremely pleased about these three-year data which further highlight IXCHIQ®‘s differentiated product profile and ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination. Whether you’re a traveler or live in an endemic region, the potential for long-term protection against a mosquito-borne disease with a single dose is crucial, particularly in low- and middle-income countries where vaccine access is often limited.”
IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S., Europe, and Canada for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Valneva recently submitted label extensions applications to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada to potentially extend the use of its chikungunya vaccine IXCHIQ® to adolescents aged 12 to 17 years. In addition to the adolescent data, the U.S. and Canadian label extension applications included IXCHIQ®’s two-year antibody persistence data for potential addition to the product label. These persistence data were already included in the initial EMA filing.
The vaccine was launched in the U.S. at the beginning of March 2024, following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations by the U.S. Centers for Disease Control and Prevention (CDC) and launches in France and Canada are currently underway.
In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil before the end of the year and expanded its partnership with CEPI earlier this year to support broader access to the vaccine in Low and Middle-Income Countries (LMICs) including outbreak-affected countries, post-marketing trials and potential label extensions in children and adolescents. CEPI is providing Valneva up to $41.3 million of additional funding over the next five years, with support from the EU’s Horizon Europe program.
Contact
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
P Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com