Valneva Announces Positive Phase 2 Results for Chikungunya Vaccine in Children
Saint-Herblain, France, January 22, 2025 – Valneva SE, a specialty pharmaceutical company focused on the development and commercialization of vaccines, has reported encouraging findings from its Phase 2 clinical trial assessing the safety and immunogenicity of two distinct dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. This trial was supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union, with the primary goal of preparing for a pivotal Phase 3 study in this age group.
Background on Chikungunya
Chikungunya is a mosquito-borne viral disease, which causes fever and severe joint pain. The disease is transmitted through the bite of an infected mosquito, primarily the Aedes mosquitoes. Symptoms typically appear within 1-12 days after being bitten and can last for several weeks or even months. Although chikungunya is not fatal, it can significantly impact a person’s quality of life due to the debilitating joint pain and swelling. There is currently no approved vaccine to prevent chikungunya, making the development of a safe and effective vaccine a critical priority.
Phase 2 Clinical Trial Results
The Phase 2 trial demonstrated that both dose levels of IXCHIQ® were generally well-tolerated and generated robust immune responses in children. The vaccine was administered to children between the ages of 2 and 16 years old, with 152 participants receiving the lower dose and 152 receiving the higher dose. The primary endpoints of the trial were the evaluation of safety, reactogenicity, and immunogenicity. The results showed:
- Both dose levels of the vaccine were generally well-tolerated, with no serious adverse events reported.
- The higher dose level demonstrated a stronger immune response, with 100% of participants showing a detectable antibody response.
- The lower dose level also showed a good immune response, with 96% of participants demonstrating a detectable antibody response.
Impact on Individuals
For individuals living in areas where chikungunya is endemic or traveling to such areas, the development of a safe and effective vaccine is essential. The positive results from Valneva’s Phase 2 trial represent a significant step forward in the quest for a chikungunya vaccine. If approved, IXCHIQ® could provide protection against this debilitating disease for children, offering peace of mind and improved overall health.
Impact on the World
Chikungunya is a global health concern, with more than 1.8 million reported cases annually. The disease is endemic in countries in Africa, Asia, Europe, and the Americas. The positive Phase 2 results for IXCHIQ® could lead to the initiation of a pivotal Phase 3 study in the fourth quarter of 2025, potentially expanding the product label to include children. Such a vaccine would have a significant impact on public health, particularly in areas where chikungunya is most prevalent, reducing the burden on healthcare systems and improving the overall quality of life for millions of people.
Conclusion
Valneva’s positive Phase 2 results for its single-shot chikungunya vaccine, IXCHIQ®, represent a significant milestone in the development of a vaccine for this debilitating disease. The promising safety and immunogenicity data in children pave the way for a pivotal Phase 3 study, which could potentially lead to the approval and availability of a much-needed vaccine for children. The potential impact on individuals and the world, particularly in areas where chikungunya is most prevalent, is immense, offering protection against this mosquito-borne disease and improving overall public health.
Stay tuned for updates on the progress of the Phase 3 study and the potential availability of this vital vaccine.
