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influenza vaccine (CSL425 / Panvax, H1N1)

✓ Approved

CSL Limited · 疫苗 · 疫苗

什么是 influenza vaccine？

influenza vaccine 是一种疫苗，由CSL Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Subcutaneous Injection。

药物档案

商品名CSL425, Panvax, H1N1
公司CSL Limited
药物类别疫苗, 大分子
给药途径Injectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, CSL Limited

相关研究文献

PubMedEpidemiology and infection2026-10-26

An investigation into post-pandemic ethnic group and deprivation inequalities in influenza and COVID-19 hospitalizations.

Scott Meg M, Browning Lucy L, Roberts Tirion T, De Boer Jessica J et al.

Health system decision-makers need evidence on how modifiable factors contribute to inequalities to inform effective interventions. We examined ethnic group and deprivation inequalities in influenza and COVID-19 hospitalizations in England (2023-2024) among vaccine-eligible individuals, using causal mediation analysis to assess the roles of deprivation, vaccination uptake and comorbidities. For influenza, hospitalization odds were highest among Pakistani and Bangladeshi groups, compared with White British individuals. Deprivation mediated 26% of the total ethnic group effect for the Pakistani group and 41% for the Bangladeshi group, whilst comorbidities contributed little. Ethnic group differences in COVID-19 hospitalizations were minimal in this post-pandemic period. For both infections, the most deprived group had disproportionately high hospitalization compared to the least deprived. For influenza, vaccination uptake mediated 17%-26% of deprivation effects, whilst for COVID-19, there were no meaningful residual deprivation inequalities after including vaccination uptake and comorbidities. Vaccination uptake and deprivation mediate a substantial proportion of inequalities in hospitalization for influenza and COVID-19 in the vaccine-eligible cohort. Improving vaccination coverage in under-vaccinated groups should remain a public health priority.

PMID 42929057
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PubMedNature communications2026-10-26

Extended dosing intervals enhance the durability of a self-amplifying mRNA vaccine against pandemic H5N1 influenza: a randomized, observer-blind, dose-finding Phase I study.

Pragalos Antoinette A AA, Pacciarini Filippo F, Jin Hongfan H, Hopkins Terri T et al.

Avian influenza poses a persistent pandemic threat, yet traditional vaccines face production delays. Self-amplifying mRNA (sa-mRNA) technology offers potential advantages, including rapid development, dose sparing, and enhanced, durable immunity. We evaluated ARCT-2304, a bicistronic sa-mRNA vaccine encoding H5N1 hemagglutinin (HA) and neuraminidase (NA), in a Phase 1 randomized, observer-blind trial (NCT06602531). Healthy adults (N = 212) received two doses of ARCT-2304 (1.5, 5, or 12 mcg) or control/placebo on a 4- or 8-week schedule. Primary outcomes evaluated safety and reactogenicity (solicited/unsolicited/serious adverse events [AEs]) and immunogenicity (HA inhibition and NA enzyme-linked lectin assays 28 days post-second dose). Immunogenicity results were benchmarked using serum from a prior study supporting licensure of an H5N1 vaccine. ARCT-2304 was well-tolerated, displaying mostly mild-to-moderate, transient, dose-dependent solicited AEs, with no safety concerns identified. Two doses elicited robust HA and NA humoral responses. An 8-week interval yielded higher magnitude and greater durability than a 4-week schedule, with neutralizing and anti-NA antibodies remaining significantly elevated 6-7 months post-second dose. ARCT-2304 also induced dose-dependent, Th1-polarized T-cell responses peaking at Day 29. These findings support advancing sa-mRNA platforms for pandemic influenza preparedness.

PMID 42928290
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PubMedInternational journal of technology assessment in health care2026-10-26

A clinical service line investment recovery framework for medical equipment: method specification and a retrospective records-based feasibility application.

Shibuya Takashi T, Kutsuna Nobuo N

Hospitals may not preserve the assumptions approved for medical-equipment purchases alongside post-adoption financial and value outcomes. We specified a clinical service line (CSL) investment recovery framework and examined its initial feasibility using routine hospital records. Targeted mapping of health technology assessment (HTA), lifecycle HTA, management accounting, and organizational learning concepts was followed by internal logic checks. A retrospective records-based application was conducted for one purposively selected 4 K arthroscopy camera-head investment at a Japanese acute-care hospital. Aggregate fixed-asset, lease, and claims records were analyzed descriptively without patient-level data or causal attribution. The framework links CSL definition, pre-adoption commitments, annualized investment burden (AIB), contribution margin (CM), evidence status, allocation, value guardrails, and feedback. The 72-month lease had a total value of JPY 4,728,240 and a minimum documented annual burden of JPY 788,040. Shoulder arthroscopy volume increased from 220 to 245 procedures (11.4 percent), and nominal procedure-fee revenue increased from JPY 102.8 million to JPY 114.9 million (11.8 percent) between 12-month periods. Planned values, variable costs, direct use logs, and prespecified quality or access indicators were unavailable; CM-based recovery metrics could not be calculated. The documented annual burden equaled JPY 31,522 per observed additional procedure, or 6.52 percent of the observed revenue increase under full attribution. The framework operationalizes hospital-level post-adoption and lifecycle HTA as an auditable CSL process. The application demonstrated partial data availability and identified fields that must be preserved prospectively; it did not establish causality, actual recovery, acceptability, or decision impact.

PMID 42929660
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PubMedNature communications2026-10-26

Reoviridae-derived short trimerization domain for stabilizing homo-trimerization of vaccine immunogens and therapeutic proteins.

Wei Min M, Bu Qingfang Q, Xiao Jin J, Yuan Lunzhi L et al.

Trimerization motifs play pivotal roles in structural biology and therapeutic protein engineering. Here, we describe a short trimerization motif (rFd1303) derived from the Reoviridae family reovirus σ1 protein. Compared with the widely used T4-Foldon, the rFd1303 increased recombinant protein yields. The rFd1303-fused immunogens of SARS-CoV-2 spike and influenza hemagglutinin elicited antibody responses comparable to T4-Foldon-fused controls in mice. Using this tag, we engineered a trimeric ACE2-Ig fusion protein (TriACE2-Ig) that remained stable after 30 days at room temperature and neutralized a broad range of ACE2-utilizing sarbecoviruses, including 19 SARS-CoV-2 variants, SARS-CoV, and pangolin coronaviruses GD and GX, with higher potency than monomeric ACE2-Ig. In the hamster model challenged with various SARS-CoV-2 variants, our data demonstrated that intranasal TriACE2-Ig administration markedly reduced viral loads, virus-induced body-weight loss, lung pathology, and decreased within-cage virus transmission. These findings highlight rFd1303 as a versatile trimerization platform for vaccine and therapeutic protein development.

PMID 42928093
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PubMedBMC cancer2026-10-26

Single-cell transcriptomic atlas of gastric cancer reveals malignant cell heterogeneity and nominates EMB as a candidate prognostic biomarker.

Ma Zheng Z, Huang Na N, Ren Bingjie B, Wang Tianran T et al.

Gastric cancer (GC) shows marked cellular heterogeneity and a complex immune microenvironment, which limits reliable biomarkers and therapeutic targets. We constructed a primary GC single-cell atlas to resolve malignant cell states linked to prognosis and to identify candidate targets. Single-cell transcriptomes from tumor, adjacent/normal, and premalignant gastric tissues were integrated. After quality control and doublet removal, data were batch-corrected, clustered, and annotated. Malignant epithelial cells were inferred from large-scale copy-number variation patterns and re-clustered. A prognostic signature was constructed by using the top marker genes of the low-differentiation ARHGDIB⁺ malignant epithelial state as a biologically informed candidate pool, followed by univariable Cox regression and LASSO Cox modeling in the TCGA stomach adenocarcinoma cohort. Survival was evaluated by Kaplan-Meier analysis with log-rank testing, and discrimination was assessed by time-dependent receiver operating characteristic analysis. Immune context was estimated by computational deconvolution and Tumor Immune Dysfunction and Exclusion scoring. Cell-cell communication was inferred from ligand-receptor expression. EMB expression across GC cell lines was assessed using CCLE/DepMap data, and EMB knockdown efficiency was validated by RT-qPCR. EMB function was tested by shRNA knockdown followed by wound-healing and Matrigel Transwell invasion assays and immunoblotting of epithelial-mesenchymal transition markers. Thirteen major cell populations spanning epithelial, immune, and stromal lineages were identified. Copy-number analysis separated malignant from non-malignant epithelium and resolved 8 malignant epithelial clusters. An ARHGDIB+ malignant epithelial state showed the lowest differentiation state and highest stem-like potential. A seven-gene signature stratified patients into high- and low-CSL groups; the high-CSL group had worse overall survival and showed bulk-level immune features consistent with an inflammatory but impaired immune context, including an increased CIBERSORT-estimated M2 macrophage fraction and higher dysfunction/exclusion scores. EMB was prioritized as a candidate prognostic hub gene, and EMB-high cells within the ARHGDIB+ malignant epithelial subcluster showed inferred ligand-receptor interactions with monocytic/macrophage-related immune populations. EMB knockdown reduced gastric cancer cell migration and invasion and shifted epithelial-mesenchymal transition markers, increasing E-cadherin and decreasing N-cadherin. This primary GC single-cell atlas identifies a low-differentiation ARHGDIB⁺ malignant epithelial state and uses its marker genes to derive a seven-gene CSL signature associated with poor prognosis and bulk tumor-level immune features. EMB emerges as a candidate biomarker and functional mediator of GC cell migration and invasion, warranting further mechanistic validation.

PMID 42928163
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PubMedCancer discovery2026-10-26

First mRNA Cancer Vaccine Succeeds in Phase III Trial.

Adding the mRNA-based individualized neoantigen vaccine intismeran autogene to the PD-1 inhibitor pembrolizumab following surgery for melanoma reduced the risk of disease recurrence or death by 42%, according to the results of the phase III INTerpath-0001 trial. The data were presented at the ESMO Congress 2026, held October 23-27, in Madrid, Spain.

PMID 42929716
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