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Shigella flexneri/sonnei bivalent live vaccine (freeze-dried) (Shigella FS vaccine)

✓ Approved

China National Pharmaceutical · 细胞治疗 · 细胞治疗

什么是 Shigella flexneri/sonnei bivalent live vaccine (freeze-dried)?

Shigella flexneri/sonnei bivalent live vaccine (freeze-dried) 是一种细胞治疗,由China National Pharmaceutical研发。该药已获批,用于治疗相关适应症,给药途径:Oral (PO)。

药物档案

商品名Shigella FS vaccine
公司China National Pharmaceutical
药物类别细胞治疗, 疫苗
给药途径Oral (PO)
状态Approved

相关研究文献

PubMedFrontiers in immunology2026-09-10

A bivalent oral yeast vaccine displaying Nocardia seriolae FHA and LMBV MCP confers protection in largemouth bass (Micropterus salmoides).

Lu Jianfei J, Gu Boge B, Yu Pengzhen P, Chen Jiong J

Largemouth bass ranavirus (LMBV) and Nocardia seriolae are major pathogens affecting largemouth bass (Micropterus salmoides), causing significant economic losses. In this study, recombinant yeasts expressing the fibronectin-binding protein A (FHA) of N. seriolae or the major capsid protein (MCP) of LMBV were constructed using the yeast surface display (YSD) system. Based on these recombinant strains, a bivalent oral yeast-based vaccine was developed and its protective efficacy was systematically evaluated. Oral administration of the vaccine induced specific antibodies against FHA and MCP in serum, as well as increased the transcription levels of adaptive immune genes (IgM, IgT, MHC-II) and innate immune genes (IL-1β, TNF-α, IFN-1, Mx2) in the hindgut, liver, and spleen. Importantly, the bivalent oral vaccine provided significant protection against both pathogens in largemouth bass, with relative percent survival (RPS) values of 56.7% against N. seriolae and 63.3% against LMBV. Meanwhile, the oral vaccine reduced pathogen loads and alleviated histopathological lesions. In summary, these findings suggest that the bivalent oral vaccine developed in this study could serve as a promising strategy for controlling N. seriolae and LMBV infections in largemouth bass aquaculture.

PMID 42718698
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PubMedFrontiers in public health2026-09-10

Correction: Economic evaluation of including the EV71 vaccine in the national immunization program: a modeling study in Guangxi, China.

He Quan Q, Liao Xiaoting X, Deng Linlin L, Su Zhengqin Z et al.

[This corrects the article DOI: 10.3389/fpubh.2026.1842766.].

PMID 42719227
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PubMedFrontiers in psychiatry2026-09-10

Barriers to oral healthcare for autistic children in China.

Wang Xing X, Huang Xuchen X

PMID 42719090
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PubMedmBio2026-09-10

Targeting conserved interaction surfaces of alphavirus nsP4 supports the rational design of live-attenuated vaccine candidates.

Yang Xiaoyao X, Väljaots Evelin E, Li Kaiyu K, Naumenko Krystyna K et al.

Alphaviruses are emerging arboviruses that pose a growing threat to global public health; however, effective interventions remain limited. Recent structural studies of the chikungunya virus (CHIKV) replicase core revealed that the viral RNA-dependent RNA polymerase nsP4 interacts with both nsP1 and nsP2 and is predicted to engage viral RNA. The conservation and multifunctionality of nsP4 make it a challenging but promising target for rational attenuation. Here, we evaluated 58 structure-guided mutations in nsP4 predicted to disrupt interactions with nsP1, nsP2, or viral RNA using a trans-replicase system. Sixteen selected mutations were further analyzed in a CHIKV-o'nyong-nyong virus chimera and Semliki Forest virus (SFV). Most mutants were viable but showed varying degrees of attenuation in mammalian and mosquito cells. Viruses carrying mutations in predicted RNA-interaction sites frequently acquired pseudoreversions and/or second-site compensatory changes, whereas those harboring mutations affecting nsP1 or nsP2 interfaces were more genetically stable. Three substitutions representing defects in nsP1 interaction (F164A), predicted RNA interaction (K174S), and nsP2 interaction (D393A) were further characterized in authentic CHIKV and displayed attenuation consistent with that observed in SFV. In vivo, all three variants showed reduced pathogenicity in the SFV mouse model, with F164A being avirulent, immunogenic, and conferring complete protection against lethal challenge. In a CHIKV mouse model, these mutations attenuated disease and reduced serum virus titers and inflammatory cell infiltration. Together, these findings provide a molecular framework for the rational design of live-attenuated alphavirus vaccine candidates and support broader evaluation of nsP4-based attenuation. Alphaviruses are an increasing global health concern, with hundreds of thousands of chikungunya cases reported worldwide in 2025; however, vaccine options remain limited, and no specific antiviral treatment is available. Recent structural studies have revealed conserved functional interfaces in the viral RNA polymerase nsP4, but their value for attenuation had not been systematically explored. Here, using structure-guided mutagenesis, validation in multiple viral systems, and in vivo analysis, we show that selected nsP4 mutations can strongly attenuate replication and pathogenicity while preserving immunogenicity. These findings identify conserved nsP4 interfaces as a shared vulnerability of alphaviruses and provide a molecular framework for the rational design of broadly applicable live-attenuated vaccines while also highlighting nsP4 as a functionally constrained target relevant to antiviral development.

PMID 42720322
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PubMedAAPS PharmSciTech2026-09-10

Real-Time Monitoring of Tablet API Concentration and Bioavailability via Dissolution Kinetics in Simulated Stomach Fluid by T-Ray Transmission Technique.

Rahman Anis A, Islam Rafiq R, Michniak-Kohn Bozena B

This paper introduces a real-time, separationless method for monitoring Active Pharmaceutical Ingredient (API) concentration and dissolution kinetics in oral tablets using terahertz radiation (T-ray) transmission kinetics within simulated stomach fluid. Unlike conventional techniques such as High-Performance Liquid Chromatography (HPLC), which produce only discrete data points and require labor-intensive sample preparation, the T-ray approach offers continuous, quantitative measurement and monitoring. By leveraging the unique transmission and absorption characteristics of APIs in the T-ray region, this technique enables precise, real-time quantification of API concentration without physically separating excipients from the sample. The technique captures comprehensive kinetic profiles, providing deeper insights into dissolution processes and underlying molecular interactions. Its application can enhance Process Analytical Technology (PAT) by facilitating immediate, real-time quality control and supporting continuous manufacturing in the pharmaceutical industry. Additionally, the data generated can strengthen the modeling of in vitro-in vivo correlations (IVIVC), which is crucial for drug development and bioavailability assessment. Overall, the T-ray transmission technique represents a robust, efficient, and sustainable analytical tool for pharmaceutical research and production, offering significant advantages over traditional methods in both accuracy and operational speed.

PMID 42717175
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PubMedFrontiers in cellular and infection microbiology2026-09-10

Isolation, characterization, and pathogenic mechanisms of a novel Lawsonia intracellularis train from Guangdong, China: impacts on digestive enzymes and gut microbiota.

Zhu Yibin Y, Wang Ao A, Wang Lianxiang L, Qi Nanshan N et al.

Lawsonia intracellularis causes Porcine Proliferative Enteritis (PPE), leading to significant economic losses, yet obtaining isolates for vaccine development remains challenging. In this study, a novel L. intracellularis strain, designated LIGD01, was isolated from the ileum of a pig with acute hemorrhagic enteritis in Guangdong, China. The strain was stably passaged in McCoy cells for 40 generations. Phylogenetic analysis of the 16S rRNA gene confirmed its identity, and indirect immunofluorescence assay (IIFA) and scanning electron microscopy (SEM) demonstrated characteristic intracellular colonization and curved rod-shaped morphology. LIGD01 induced intermittent fecal shedding starting at 3 days post-infection (dpi), with seroconversion in all challenged pigs by 21 dpi. Necropsy revealed distinct ileal hyperplasia. Histopathology showed villous blunting, epithelial exfoliation, and inflammatory infiltration. Crucially, infection significantly reduced Average Daily Gain (ADG) (252.21 ± 17.07 g/day vs. 300.98 ± 19.39 g/day in controls, p < 0.05) and suppressed the activities of key digestive enzymes (trypsin, lipase, amylase) in the pancreas and intestine. Furthermore, Lawsonia intracellular infection characterized by a reduction in beneficial genera (Lactobacillus, Christensenellaceae) and an increase in opportunistic pathogens (Streptococcus, Enterococcus), concomitant with upregulated pro-inflammatory cytokines (TNF-α, IFN-γ, IL-1α). This study not only provides a new candidate strain for vaccine development but also elucidates the physiological and microbial mechanisms underlying growth retardation in PPE.

PMID 42718558
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