IXCHIQ chikungunya vaccine meets phase 2 endpoint in children
Already approved in those aged 18 and older in the United States, Valneva has submitted label extension applications to the FDA for IXCHIQ use in adolescents aged 12 to 17 years.
IXCHIQ chikungunya vaccine meets phase 2 endpoint in children | Image Credit: © Monir - © Monir - stock.adobe.com.
Valneva's single-shot chikungunya (CHIKV) vaccine, IXCHIQ (Chikungunya Vaccine, Live), has demonstrated positive phase 2 data among children, according to a recent announcement from the company.1,2
The manufacturer reported that IXCHIQ met its primary endpoint in the phase 2 VLA1553-221 trial (NCT06106581) demonstrating it was well tolerated in children aged 1 to 11 years, regardless of a half or full dose, or previous CHIKV infection. It was also well tolerated to active control MenACYW vaccine (Nimenrix).1
The data revealed that the safety profile of IXCHIQ was consistent with the profile observed in phase 3 trials among adults and adolescents.1
Currently, IXCHIQ is approved by the FDA for the prevention of disease caused by CHIKV in individuals aged 18 years and older who are at an increased risk of CHIKV exposure.2
The phase 2, multi-center, randomized, observer-blinded, and dose response trial featured 304 healthy children aged 1 to 11 years. Primary and secondary endpoints of the trial are to evaluate the safety and immunogenicity of 2 different dose levels of the single-shot vaccine.1
Performed at 3 trial sites in the Dominican Republic and Honduras, study participants were randomized 2:2:1 to receive either a full dose, half dose of the vaccine, or an active control in Nimenrix.
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 in the announcement.
According to the company, based on the full and half dose in post-vaccination safety and tolerability, as well as a "more pronounced" immune response of the full dose in children of all ages tested, results "confirm the suitability of the full dose for this population and led to the selection of this dose (licensed IXCHIQ® formulation and presentation) for the pivotal Phase 3 evaluation in participants aged one to eleven years."
“These first data in children are aligned with the robust antibody response and good safety profile we reported in both adolescents and adults after a single vaccination," Juan Carlos Jaramillo MD, chief medical officer of Valneva, said in a statement.
"Considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, it’s crucial to ensure that the vaccine is accessible to people of all ages and capable of potentially offering long-term protection from a single shot," said Jaramillo.
References:
1. Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision. Valneva. Press release. January 22, 2025. Accessed January 23, 2025. https://www.biospace.com/press-releases/valneva-reports-positive-phase-2-results-in-children-for-its-chikungunya-vaccine-and-announces-phase-3-dose-decision
2. IXCHIQ. FDA. Updated 1/10/2024. Accessed 1/23/2025. https://www.fda.gov/vaccines-blood-biologics/ixchiq
