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Shigella flexneri 2a whole cell vaccine + double mutant E. coli heat labile toxin

Development stage
Unknown
Lead developer
PATH
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

This is an oral combination vaccine candidate composed of a formalin-inactivated whole-cell *Shigella flexneri* 2a (Sf2aWC) and the double mutant *Escherichia coli* heat-labile toxin (dmLT; LT R192G/L211A) as a mucosal adjuvant. The primary indication is prevention of shigellosis caused by *Shigella flexneri* 2a, a major cause of severe diarrhea worldwide. The inactivated bacterial component induces immune responses against the lipopolysaccharide (LPS) and other antigens of *S. flexneri* 2a, while the dmLT adjuvant enhances both systemic and mucosal immunity by promoting IL-17A production from CD4+ T cells via antigen-presenting cells and cytokines such as IL-1β and IL-23[3][6][8]. Clinical studies have shown that this combination is safe, well-tolerated, immunogenic in adults, and capable of inducing robust anti-LPS antibody responses[3][5]. The addition of dmLT aims to further boost mucosal immune responses for improved protection.

Other names
Shigella flexneri 2a inactivated whole cell vaccine + double mutant Escherichia coli heat labile toxinSf2aWC + dmLTformalin-inactivated Shigella flexneri 2a whole cell vaccine with dmLT adjuvant
02

Targets

GM1 (GM1 ganglioside)

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