Workflow
Chikungunya Vaccine Development
icon
Search documents
Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children
Globenewswireยท 2025-06-12 06:00
Core Points - Bavarian Nordic has initiated a Phase 3 clinical study for its chikungunya vaccine, CHIKV VLP, targeting children aged 2 to 11 years, expanding its current approval for individuals aged 12 and older [1][2][3] Group 1: Vaccine Development - The Phase 3 study aims to evaluate the safety and immunogenicity of the CHIKV VLP vaccine in 720 children over two years, with primary results expected in the first half of 2028 [2] - VIMKUNYA (CHIKV VLP) is the first and only virus-like particle vaccine for chikungunya, designed to induce a robust immune response, with protective immunity developing as early as one week post-vaccination [3][4] - The vaccine is non-infectious, does not contain viral genetic material, and is available as a single-dose prefilled syringe [3] Group 2: Regulatory Approvals - VIMKUNYA received approvals from the U.S. FDA, European Commission, and the UK in early 2025 based on results from two Phase 3 trials involving over 3,500 healthy individuals aged 12 and older [4][5] - The trials demonstrated that 21 days post-vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of participants aged 12 to 64, and 87.3% in those over 65 [5] Group 3: Disease Background - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, causing significant outbreaks and presenting with acute symptoms such as fever and severe joint pain [6] - In 2024, there were 620,000 reported cases of chikungunya globally, with over 200 deaths, indicating a potential underreporting of the disease [6]