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influenza vaccine

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BIKEN · 重组蛋白 · 重组蛋白

什么是 influenza vaccine？

influenza vaccine 是一种重组蛋白，由BIKEN研发。该药已获批，用于治疗相关适应症，给药途径：Intramuscular (IM) Injection、Subcutaneous Injection。

药物档案

公司BIKEN
药物类别重组蛋白, 疫苗
给药途径Intramuscular (IM) Injection, Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, BIKEN

相关研究文献

PubMedmBio2026-09-10

Sex and age differences in antibody responses to seasonal influenza vaccination are mediated by estrogenic upregulation of NF-κB and TNF signaling in B cells.

Park Han-Sol H-S, Yin Anna A, Zhou Weiqiang W, Wenstedt Eliane F E EFE et al.

Sex differences in the humoral immune responses to the seasonal quadrivalent influenza vaccine (QIV) in young adults (YA; 18-49 years old) or high-dose QIV in old adults (OA; 75+ years old) were analyzed to determine how age-related changes, including in steroids, impact sex differences in B cells. Among YAs, females had greater H3N2, but not H1N1, neutralizing antibody titers, and greater proportions of hemagglutinin (HA)+ CD19+ B cells and HA+ memory B cells than males through 28 days post-vaccination (DPV), that was not observed among OAs. Machine learning algorithms illustrated that baseline (0 DPV) steroids, including 17-hydroxyprogesterone, estrogens, and testosterone, as well as HA+ CD19+ B cells and HA+ antibody-secreting B cells (ASCs), were major predictors of seroconversion at 28 DPV, particularly in YA. Single-cell RNA sequencing demonstrated that CD19+ B cells from YA females had greater transcriptional activity at 7 DPV than YA males, with upregulation of genes with estrogen-response elements (EREs) along NF-κB-mediated TNF signaling pathways in B-cell subsets, which was mitigated in OA. Estradiol treatment of ASCs from YA females, but not males, increased the number and size of HA+ IgG+ cells and expression of ERE genes along the NF-κB-mediated TNF signaling pathway,that was inhibited by an estrogen receptor antagonist. Pharmacological inhibition of either NF-κB or TNF signaling blocked the ability of E2 to upregulate antibody secretion in cells from YA females. This study provides mechanistic insights into estrogen-mediated increases in influenza vaccine-induced antibody responses among reproductive-aged females and suggests a role for estrogen signaling in the reduction of sex differences in vaccine-induced immunity with old age. Sex differences in influenza vaccine-induced immune responses become less pronounced with old age, which we hypothesize could be related to changes in circulating gonadal steroids. Our study shows that after receipt of the seasonal influenza vaccine, young adult females, who have elevated estrogenic activity, have more B cells that recognize influenza hemagglutinin; their B cells have greater activity along estrogen signaling and inflammatory pathways, and mount stronger antibody responses than young adult males, with these sex differences being mitigated in old adults. We identify estrogen as a key driver of sex differences in influenza immunity by showing that ex vivo estradiol increases antibody production by B cells through the estrogen receptor and engagement with NF-κB. These findings help explain the biological basis for sex differences in vaccine immunity and suggest that the hormonal environment, not just chronological age, shapes how well a person responds to vaccination.

PMID 42720319
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PubMedAmerican journal of epidemiology2026-09-10

Influenza mitigation recommendations, symptoms, and viral RNA shedding durations-2023-24 and 2024-25 seasons.

White Elizabeth B EB, O'Neil Caroline A CA, Stockwell Melissa S MS, McLaren Son H SH et al.

In March 2024, CDC released symptom-based isolation guidance for viral respiratory illnesses including influenza: isolation from others until fever-free for 24 hours and other symptoms are improving, followed by 5 days of post-isolation precautions. This study evaluated how well these recommendations aligned with influenza virus RNA shedding and assessed self-reported isolation in a multi-site household study during 2023-2025. We analyzed data from 1294 participants with influenza, including 627 with a clear peak in viral RNA levels and symptom resolution during follow-up. Participants provided daily symptom diaries and nasal swabs. We used Kaplan-Meier models to estimate recommended isolation duration based on CDC guidelines and compared this to viral RNA shedding measured by cycle threshold values and viral loads. The median recommended isolation duration was 6 days (interquartile range 4-7). Peak viral RNA shedding occurred a median of 4 days post-symptom onset, falling during recommended isolation for 80% (by Ct) and 69% (by viral load) of participants and increasing to 100% and 97% respectively by day 6 post-isolation. However, only 21% reported isolating from household members (median 2 days), and 80% isolated from the community (median 4 days). These findings support symptom-based isolation and emphasize the importance of post-isolation precautions.

PMID 42720580
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PubMedCritical pathways in cardiology2026-09-10

Effect of Influenza Vaccination on Major Cardiovascular Events and Mortality: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Shahid Muhammad Waqar MW, Hameed Abdullah A, Naseem Ayesha A, Sajjad Fatima F et al.

Cardiovascular disease remains the leading global cause of mortality despite advances in preventive therapies. Influenza infection is increasingly recognized as a trigger for acute cardiovascular events, prompting interest in influenza vaccination as a potential cardioprotective intervention in high-risk patients. We aimed to conduct a systematic review and meta-analysis to evaluate the effect of influenza vaccination on cardiovascular outcomes in adults with established cardiovascular disease. PubMed, Embase, and Cochrane databases were systematically searched using relevant keywords from inception until October 2025. Seven studies were included after the final screening. Outcomes were reported as all cause mortality, myocardial infarction, major adverse cardiovascular events and heart failure related hospitalization. Interstudy heterogeneity was assessed using I² and X² statistics. Statistical calculations were performed using Review Manager 5.4.1, with a p-value of < 0.05 indicating statistical significance. Seven randomized controlled trials including 12,224 participants were analyzed. Influenza vaccination significantly reduced major adverse cardiovascular events and cardiovascular mortality. A borderline reduction was observed for myocardial infarction and all-cause mortality. No significant differences were found for stroke, coronary revascularization, or heart failure-related hospitalization. Heterogeneity was low for most primary outcomes. The routine use of influenza vaccination as an effective adjunctive strategy in secondary cardiovascular prevention is supported by the fact that it significantly lowers cardiovascular mortality and major cardiovascular events in patients with established heart disease.

PMID 42720234
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PubMedJournal of medicinal chemistry2026-09-10

Structure-Based Design and Optimization of Onradivir-Derived PB2 Inhibitors for the Treatment of Influenza A.

Yang Yujian Y, Rong Binhao B, Zhou Xingyu X, Liu Yongqing Y et al.

Influenza A remains a major seasonal public health burden. With the approval of onradivir, PB2 has emerged as an attractive antiviral target due to its unique and conserved structural features. Herein, using onradivir as the lead, we employed bioisosteric replacement strategies to design a series of derivatives for SAR studies. Compound 5B, bearing a cyano carboxamide moiety, exhibited strong antiviral activity with a superior safety index relative to onradivir, along with broad-spectrum inhibition against H1N1 and H3N2 strains. In an H1N1-infected mouse model, oral administration of 5B reduced lung viral load and ameliorated virus-induced pulmonary pathology and inflammatory responses. Remarkably, oral administration of 5B significantly improved survival (85.7% across all dose groups), outperforming onradivir at equivalent doses. Consistently, 5B exhibited favorable oral bioavailability, supporting sufficient plasma exposure. Molecular dynamics simulations revealed a highly stable complex with the PB2 cap-binding domain. These findings establish 5B as a promising preclinical candidate for influenza A.

PMID 42720457
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PubMedEmerging microbes & infections2026-09-10

AXL mediates influenza A virus entry and drives virus-induced inflammation.

Zuo Wenting W, He Di D, Wang Donghong D, Lyu Chen C et al.

Influenza A virus (IAV) infection remains a persistent global health challenge with limited antiviral drugs. Viral entry represents a potential multifaceted target for antiviral intervention; however, there is a limited number of approved inhibitors that effectively prevent IAV entry. Here, we identify the receptor tyrosine kinase AXL as an IAV functional entry factor with dual roles in viral invasion and host immune modulation. Although AXL has been previously reported as a negative regulator of inflammation, we reveal that its inhibition simultaneously reduces viral entry and virus-induced inflammatory responses. Mechanistically, AXL mediates IAV invasion via the GAS6-AXL-AKT/ERK signalling axis and distinct endocytic pathways: clathrin-mediated endocytosis in epithelial cells and macropinocytosis-dominated endocytosis in alveolar macrophages. Consistently, AXL knockout mice or early administration of an AXL inhibitor during infection markedly reduced pulmonary viral loads, attenuated virus-induced cytokine production and lung pathology, and improved survival. Beyond IAV, AXL also contributes to the entry of SARS-CoV-2, MERS-CoV, and human metapneumovirus (hMPV), suggesting its potential as a broad-spectrum host-directed antiviral target. Collectively, our findings provide the first in vivo and in vitro evidence that AXL functions dually as a viral entry factor and immune modulator, highlighting its promise as a therapeutic target to block infection and control virus-induced inflammation.

PMID 42717575
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PubMedBMC medical informatics and decision making2026-09-10

Machine learning-assisted mRNA vaccine pharmacovigilance: a systematic review of multi-source real-world data.

He YuLong Y, Mao Yan Y, Wang XinYu X

The rapid deployment of mRNA vaccines during the COVID-19 pandemic exposed limitations in traditional pharmacovigilance systems, including delayed reporting, high underreporting rates, and inability to calculate true incidence. Machine learning (ML) offers new pathways to overcome these challenges by integrating multi-source real-world data. We systematically reviewed English-language studies from database inception to June 2026. Searches were performed in PubMed, Embase, and Web of Science. Two reviewers independently screened records. Given substantial heterogeneity across ML tasks (signal detection, text extraction, risk prediction, prognosis stratification), algorithms, data sources, and metrics, we performed narrative synthesis. Risk of bias was assessed using adapted QUADAS-2. We identified 43 studies. For adverse-event prediction, tree-based models reported AUCs of 0.85-0.87, though estimates derive from heterogeneous settings. NLP reduced redundant signals by 17% in vaccine reporting systems. For myocarditis, ML models reached AUCs up to 0.899 in cardiovascular cohorts, but direct mRNA vaccine applications remain limited and retrospective. Emerging platforms (self-amplifying and tumor mRNA vaccines) lack post-marketing data, rendering ML applications largely conceptual. ML-assisted pharmacovigilance enables a shift from passive to active, intelligent monitoring. Despite challenges in data quality, model interpretability, and regulatory approval, intelligent pharmacovigilance systems will become essential infrastructure for safeguarding public health.

PMID 42717339
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