Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year1, particularly among children in Low- and Middle-Income Countries.
S4V2 – The World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
- Shigella4V2 (S4V2) is a tetravalent bioconjugate vaccine candidate against shigellosis.
- Valneva in-licensed S4V2 as part of an exclusive worldwide development, manufacturing, and commercialization agreement with LimmaTech Biologics AG [2].
- No approved Shigella vaccine is currently available and the development of Shigella vaccines has been identified as a priority by the World Health Organization [3].
- In addition to the local LMICs populations, Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions.
- LimmaTech reported positive Phase 1/2 results for S4V2, including a favorable safety and tolerability profile as well as robust data on immunogenicity against the four most common pathogenic Shigella serotypes, S. flexneri 2a, 3a, 6, and S. sonnei [4].
- In October 2024, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to S4V2.
- Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial, and a Phase 2b Human Challenge trial (CHIM), sponsored by LimmaTech Biologics AG, are ongoing. Results from both studies are expected in the third quarter of 2026 [5].
Additional information about Shigella:
- Shigellosis | CDC Yellow Book 2024
- Press Release: Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
- https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/shigella
- Press Release: LimmaTech Biologics Reports Positive Interim Phase I/II Clinical Data on Tetravalent Shigella Bioconjugate Vaccine S4V
- Press Release: Valneva Reports Half Year 2026 Financial Results and Provides Corporate Updates