Bavarian Nordic initiates trial of chikungunya vaccine in children aged 2-11 years
Currently, Vimkunya is FDA-approved for use among individuals aged 12 years and older.
Bavarian Nordic initiates trial of chikungunya vaccine in children aged 2-11 years | Image Credit: © ImageKing - © ImageKing - stock.adobe.com.
On June 12, a new phase 3 clinical study of the Vimkunya single-dose, virus-like particle (VLP) chikungunya vaccine was initiated by Bavarian Nordic A/S among children aged 2 to 11 years, according to a press release from the company.1
The trial (NCT07003984) looks to expand the target population for the vaccine, which is currently FDA-approved for individuals aged 12 years and older in the United States, European Union, and United Kingdom.
The global, randomized, double-blind, and placebo-controlled study will evaluate safety and immunogenicity of the vaccine in 720 children for 2 years, with primary results expected in the first half of 2028.
"Upon the successful approvals earlier this year of our chikungunya vaccine for persons aged 12 and older, we are pleased to initiate this phase 3 study in children for whom there are currently no vaccines available to prevent against chikungunya," said Paul Chaplin, president, CEO, Bavarian Nordic, in a statement. "This study represents a significant part of our commitment to the further development of the vaccine to help ensure access for people of all ages.”
Vimkunya for aged 12 and older launched in March
Vimkunya was launched on March 18, 2025, for individuals aged 12 years and older, following its approval on February 14, 2025. The approval made it the first VLP single-dose, pre-filled syringe for chikungunya among the indicated age group. Prior to this approval, the only FDA approved vaccine for chikungunya prevention, Ixchiq (Valneva), was indicated for individuals aged 18 years and older.2
Bavarian Nordic stated the vaccine was generally well tolerated, with most adverse events categorized as mild or moderate. The company emphasized the growing global need for chikungunya prevention, as the mosquito-borne virus has spread to over 110 countries, with documented transmission in more than 50 countries within the last 5 years.
In a March 2024 meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Vimkunya for travelers aged 12 and older who are visiting areas with active chikungunya outbreaks.3
The recommendation also extends to individuals planning extended stays in regions with elevated risk and to laboratory personnel with potential occupational exposure to the virus.
The ACIP recommendation reaffirms the vaccine’s public health importance in mitigating outbreak-related risk and protecting high-exposure groups. The vote follows the same trial data supporting the FDA approval, which demonstrated strong immunogenicity and rapid onset of protection.
More on chikungunya
Ixchiq was approved on November 10, 2023, as the world's first approved vaccine for chikungunya, in individuals aged 18 years and older who are at an increased risk of exposure to the virus.2
In January 2025, Valneva reported positive phase 2 data among children aged 1 to 11 years from the VLA1553-221 trial (NCT06106581). According to results, the vaccine was well tolerated in this age group, regardless of a half of full dose, or previous chikungunya infection.
In the phase 3 trial, "A full dose of the vaccine exhibited a more robust immune response compared to a half dose by providing protective antibody titers already at Day 15 and Day 29 post-vaccination, confirming the excellent immunogenicity previously observed in adults and adolescents," stated Valneva at the time of data announcement.
Click here for more on IXCHIQ.
References:
1. Bavarian Nordic initiates phase 3 study of chikungunya vaccine in children. Bavarian Nordic. Press release. June 12, 2025. Accessed June 13, 2025. https://www.bavarian-nordic.com/media/media/news.aspx?news=7238
2. Fitch J. Vimkunya chikungunya vaccine launches for ages 12 years and older. Contemporary Pediatrics. March 18, 2025. Accessed June 13, 2025. https://www.contemporarypediatrics.com/view/vimkunya-chikungunya-vaccine-launches-for-ages-12-years-and-older
3. Fitch J. ACIP votes in favor of recently FDA approved vaccines for meningococcal disease, chikungunya. Contemporary Pediatrics. April 17, 2025. Accessed June 13, 2025. https://www.contemporarypediatrics.com/view/acip-votes-in-favor-of-recently-fda-approved-vaccines-for-meningococcal-disease-chikungunya
