Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine - Seite 2

Conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union’s Horizon 2020 program, the VLA1553-321 trial represents the first clinical trial conducted in an endemic area and with individuals previously infected with CHIKV.

Valneva’s vaccine IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. It was approved by the U.S. FDA in November 2023⁴, and the Centers for Disease Control and Prevention (CDC) recently adopted the Advisory Committee on Immunization Practices’ (ACIP) recommendations on use of the vaccine in the U.S.⁵. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (ANVISA) with potential approvals in 2024. IXCHIQ’s final pivotal Phase 3 data were published in The Lancet, the world’s leading peer-reviewed medical journal, in June 2023⁶.

About Phase 3 Study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents aged 12 to 17 years old in Brazil. The VLA1553-321 clinical trial was initiated in January 2022 and Valneva reported initial immunogenicity and safety data in November⁷ and August 2023⁸, respectively. VLA1553 or placebo was administered as a single intramuscular immunization to participants who were randomized into two study groups at a 2:1 ratio. The primary objective is to evaluate the immunogenicity and safety of the adult dose of VLA1553 in adolescents 28 days following a single vaccination. Secondary objectives of the trial include assessment of safety and immunogenicity up to twelve months following a single vaccination with VLA1553. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04650399).

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite⁹. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032¹⁰. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. The Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries¹¹. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas¹² and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.