Valneva announces the vaccination of the first participant in the Phase 2b controlled human infection trial of Shigella4V (S4V), a tetravalent shigellosis vaccine candidate for which the Group has obtained an exclusive worldwide license from LimmaTech.
In the CHIM S4V03 trial, the safety and preliminary efficacy of S4V2 will be evaluated in three clinical trial centers in the United States on approximately 120 healthy participants, aged 18 to 50, who have never contracted Shigellosis.
Valneva points out that the US FDA granted 'Fast Track' status to S4V2 last month, 'recognizing its potential to target a serious disease and address an unmet medical need'.
Shigellosis is the second leading cause of fatal diarrheal disease worldwide. There is currently no approved vaccine against it, and the development of vaccines against this disease has been prioritized by the WHO.
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Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Valneva takes a highly specialized and targeted approach, applying its deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
Valneva has a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently markets three proprietary travel vaccines.
Revenues from its growing commercial business help fuel the continued advancement of its vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats.
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