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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
来源： ClinicalTrials.gov, China National Pharmaceutical

相关研究文献

PubMedVeterinary world2026-10-26

Preclinical evaluation of a live attenuated bivalent Trichophyton vaccine for prophylaxis and post-infection treatment of dermatophytosis in rabbits.

Umitzhanov Mynbay M, Bakirov Nurbol N, Sansyzbay Abylay A, Nurpeisova Ainur A et al.

Bovine trichophytosis is a contagious zoonotic dermatophytosis that adversely affects animal health and livestock productivity and poses an occupational risk to people in contact with infected cattle. Although live attenuated vaccines have contributed to disease control, evidence for bivalent formulations targeting multiple Trichophyton species remains limited. This study evaluated the prophylactic activity and post-infection outcomes of a live attenuated bivalent vaccine candidate containing Trichophyton verrucosum and a member of the Trichophyton mentagrophytes species complex in an experimental rabbit model. Thirty-three clinically healthy rabbits were allocated to a prophylactic group (Group I, n = 10), therapeutic group (Group IIa, n = 10), infected untreated histopathology subgroup (Group IIb, n = 3), and intact control group (Group III, n = 10). Group I received two intramuscular vaccinations 14 days apart and was challenged 21 days after the second vaccination, whereas Group IIa was experimentally infected before therapeutic vaccination. Clinical manifestations, body weight, rectal temperature, hematological parameters, mycological culture, and histopathological changes were evaluated. Clinical and histopathological assessments were descriptive and non-blinded. Following experimental challenge, no clinically visible dermatophytosis lesions occurred in prophylactically vaccinated rabbits (0/10), whereas all infected untreated reference rabbits developed lesions (3/3; two-sided Fisher's exact test, p = 0.0035), supporting prophylactic activity. Therapeutically vaccinated rabbits showed progressive regression of visible crusting and hair regrowth; however, the absence of a longitudinal untreated infected group and positive treatment comparator precluded attribution of recovery specifically to vaccination. Dermatophyte growth was recovered from challenged skin after 5-7 days, although species-specific identification and quantitative fungal burden were not determined. Hematological indices showed limited descriptive variation. Histopathology demonstrated inflammatory and degenerative cutaneous lesions in untreated infected rabbits and nonspecific reactive lymphoid changes in vaccinated animals. The live attenuated bivalent vaccine candidate demonstrated promising prophylactic activity against experimental dermatophytosis in rabbits. Post-infection clinical improvement provides preliminary evidence warranting further investigation but cannot establish therapeutic efficacy. Controlled studies in the target host should incorporate adequate comparator groups, standardized lesion scoring, quantitative and species-specific mycology, immunological endpoints, and comprehensive vaccine quality control and stability assessments before field application.

PMID 42928825
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PubMedMicrobiology spectrum2026-10-26

Functional and protective capacity of a human monoclonal antibody against Shigella sonnei O-Antigen produced in fungal cells.

Vezzani Giacomo G, Mäkinen Mari M, Boero Elena E, Nannini Francesco F et al.

The number of bacterial species acquiring antimicrobial resistance to the most widely used antibiotics is steadily increasing. Monoclonal antibodies (mAbs) are among the most promising therapeutic options to tackle antimicrobial resistance. A major hurdle that prevents broader applicability of mAb therapy is represented by high production costs. Here, we describe the manufacturing of a human mAb targeting the O-Antigen of Shigella sonnei by a fungal production platform (Thermothelomyces heterothallica C1, formerly Myceliophthora thermophila). The antibody, produced with either native fungal or humanized glycosylation, had functional activity in vitro and protective efficacy in vivo comparable to the antibody generated in standard mammalian cells. The use of the C1 platform reduces production time and accelerates release, thus significantly lowering production costs. This approach can favor equitable access to novel therapeutics that can counteract global health challenges. This study demonstrates that a fungal production platform can produce a human monoclonal antibody (mAb) targeting the O‑antigen of Shigella sonnei with equivalent functional activity and protective effects to antibodies made in mammalian cells. The use of the C1 platform reduces production time and accelerates release, thus significantly lowering production costs. This approach can favor equitable access to novel therapeutics and support global efforts to control antimicrobial resistance.

PMID 42929515
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PubMedDiseases (Basel, Switzerland)2026-10-26

Divergent Human Papillomavirus Genotype Spectra in Three Indigenous Communities of Venezuela: Implications for Vaccine Choice and Cervical Screening.

Garcés María Fátima MF, Guzmán Silva Jefferson J, Aranguren Daniel D, Figueira Lina L et al.

Background: Genotype-resolved data on human papillomavirus (HPV) are almost absent for Venezuelan indigenous women. Methods: We studied 260 women from La Guajira (Wayuu, n = 94), Maniapure (Eñepa, n = 141), and Delta Amacuro (Warao, n = 25), processing all self-collected samples with a single real-time PCR assay that resolves 21 genotypes; cytology was available for 144. Results: HPV prevalence was 55.4% (95% CI 49.3-61.3) and high-risk prevalence was 51.2% (95% CI 45.1-57.2), rising from 42.6% in La Guajira to 59.6% in Maniapure and 80.0% in Delta Amacuro (p = 0.001). Nineteen genotypes were detected. HPV-31 was most frequent (15.8%), followed by HPV-16 (11.5%), and each community had its own profile, with HPV-68 and HPV-56 leading in Delta Amacuro. Half of the infected women carried more than one type. Cytology and HPV testing overlapped little: 20 of 78 HPV-positive women with a smear (25.6%) had an abnormal result (κ = 0.056). At least one nonavalent vaccine type was present in 69.4% of infected women, compared with 30.6% for the bivalent vaccine. Conclusions: HPV vaccination is not part of the Venezuelan national program; these data favor the nonavalent formulation, and HPV-based screening would need a feasible triage pathway for the many women who test positive.

PMID 42930011
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PubMedGels (Basel, Switzerland)2026-10-26

Ambient-Dried Cellulose Nanofibril/H2TiO3 Composite Aerogel for Enhanced Lithium Capture at Seawater-Relevant pH.

Wang Xueqiao X, Wang Jing J, Wang Wenxuan W, Liu Ruimeng R et al.

Efficient seawater lithium harvesting requires adsorbents combining high selectivity with scalable, low-energy fabrication. Although H2TiO3 lithium-ion sieves (HTO-LIS) exhibit exceptional Li+ selectivity, their deployment is hindered by strict alkaline requirements and reliance on energy-intensive shaping processes such as freeze-drying. Herein, we report a cellulose nanofibril (CNF) composite aerogel addressing both challenges simultaneously. Ammonium phytate (AP), a bio-derived polyphosphate, serves a dual function: as a green crosslinker for CNF and as an in situ alkalinity generator, creating a localized alkaline microenvironment around immobilized HTO nanoparticles that enables efficient topotactic H+/Li+ exchange at seawater-relevant pH 8 without requiring strongly alkaline bulk conditions. Crucially, the AP-crosslinked CNF skeleton withstands capillary forces during ambient-pressure drying, preserving a hierarchical macroporous network without freeze-drying. The resulting AP-CNF@HTO monolith achieves a Li+ capacity of 19.08 mg g-1 at pH 8, a 128.9% enhancement over pristine HTO, with excellent selectivity against competing ions in real seawater and 88.3% capacity retention after ten cycles. This work demonstrates that rational bio-based crosslinker selection can concurrently solve the alkaline microenvironment and ambient-drying challenges of HTO-LIS composites, offering an ambient-pressure-drying route with reduced reliance on energy-intensive freeze-drying for seawater lithium enrichment.

PMID 42929908
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PubMedDentistry journal2026-10-26

Fairness as an Ethical Imperative in Dental Assessment: German Students' Perspectives on Oral Examinations and Structured Assessment Formats.

Morlock Lisa L, Rampf Sarah S, Rupf Stefan S, Kowalczyk Leonhard L et al.

Background/Objectives: Oral examinations can assess clinical reasoning and professional judgement, but examiner-dependent variation and unclear expectations may compromise reliability, procedural fairness, and accountability. This study investigated German dental students' perceptions of oral examinations and identified learner-informed priorities for fair, transparent, and ethically responsible assessment. Methods: This national cross-sectional mixed-methods study used a participatory approach to questionnaire development. The main online survey was distributed to undergraduate dental students through national student networks. Three supplementary questions were administered separately to participants at the 2026 National Conference of German Dental Student Representatives. Quantitative data were analysed descriptively. Free-text responses were examined using qualitative content analysis conducted collaboratively by two researchers. Results: The main survey included 368 students from 26 dental schools, representing 84% of German dental schools; the separate conference-based dataset comprised 168 participants. Students strongly endorsed clearly defined competencies required to pass (mean 4.74 ± 0.81), transparent assessment criteria (4.64 ± 0.87), and structured questions to promote consistent and fair assessment (4.42 ± 0.99). Conference participants perceived a substantial influence of examiners on grades (4.25 ± 0.81). The qualitative findings contextualised the quantitative results across four areas: fairness and examiner influence; transparency of expectations and criteria; structure and consistency; and psychological safety, feedback, and preparation. Conclusions: Students viewed fairness, transparency, and accountability as integral to assessment quality. Structured oral examinations may support more equitable assessment while preserving opportunities to evaluate clinical reasoning and professional judgement. Because qualitative coding was conducted collaboratively rather than independently, no formal inter-rater reliability coefficient was calculated, limiting the reproducibility of the qualitative findings.

PMID 42930410
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PubMedInternational journal of fertility & sterility2026-10-26

Association between Ambient Air Pollution Exposure and Reproductive Outcomes following In Vitro Fertilization: A Retrospective Cohort Study.

Ai Zhonghua Z, Li Xuefei X, Zhuang Zitong Z, Wei Shengtao S et al.

Assisted reproductive technologies have become increasingly important in addressing infertility worldwide. Evidence on the associations between ambient air pollution exposure and biochemical pregnancy, clinical pregnancy, and live birth remains limited. Given the widespread exposure to air pollutants and the critical sensitivity of early reproductive processes, understanding these associations is essential for improving clinical outcomes in in vitro fertilization (IVF). In this retrospective cohort study, we included 12,453 infertile women who underwent fresh embryo transfer at a major assisted reproductive specialist hospital in Chengdu, China, between 2019 and 2022. Infertility etiologies included a range of female and male factors. Transferred embryos were at the cleavage stage (day 3), graded according to standard morphological criteria, or at the blastocyst stage (day 5), graded according to the Gardner scoring system. Exposure to PM2.5, PM10, O3, and NO2 was estimated at residential addresses using a bilinear interpolation approach applied to the ChinaHighAirPollutants (CHAP) 1 km×1 km gridded dataset. Outcomes included biochemical pregnancy, clinical pregnancy, and live birth, assessed using serum beta-human chorionic gonadotropin (β-hCG) testing, ultrasound confirmation, and delivery records. Associations between air pollutants and outcomes were evaluated using generalized linear models, with estimates reported as odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for key sociodemographic, clinical and paternal characteristics. Among the 12,453 participants, 7,548 achieved biochemical pregnancy, 6,550 achieved clinical pregnancy, and 5,601 achieved live birth. Exposure to air pollutants during the period from 85 days before oocyte retrieval to oocyte retrieval (period 4) was significantly associated with decreased odds of all three assisted reproductive outcomes. For live birth, each 10 μg/m3 increase in PM2.5 was associated with a 3.1% reduction in the odds (OR: 0.969; 95% CI: 0.954-0.984). Our results provide evidence that ambient air pollution exposure from 85 days before oocyte retrieval to oocyte retrieval is a significant environmental risk factor negatively affecting the biochemical pregnancy, clinical pregnancy, and live birth outcomes in IVF. These findings suggest that reducing exposure to air pollution during critical windows such as gamete development may improve reproductive outcomes.

PMID 42929017
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