This study will provide novel insight into the effects of repeat influenza vaccination with Flublok and FluMist on the strength and breadth of immune responses to influenza, the mechanisms underlying heterogeneity in vaccine response and vaccine failure, and biological factors that could explain variation in influenza vaccine effectiveness.

开始日期2025-10-01

申办/合作机构

香港大学

NCT07177417

/ Recruiting临床4期IIT

EVax-3: Human Upper and Lower Airway Mucosal Immune Response to FluMist Vaccination

The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40. The main purpose of the study is to measure the change in influenza vaccine-specific antibodies in the lower lungs and nose between vaccination and 14 days after participants receive the vaccine. All participants will be randomized to receive one of the two seasonal flu vaccines and will have blood and back of the nose swabs collected throughout the study. Some study participants will choose to undergo optional bronchoscopy procedures and will be included in the part of the study looking at lower lung immune responses.

开始日期2025-09-09

申办/合作机构

Washington University School of Medicine

[+1]

NCT05921448

/ Not yet recruiting早期临床1期IIT

In-depth Immunological Analysis of Airway Immunity Following Nasal Live Attenuated and Intramuscular Influenza Vaccine

The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.

开始日期2025-08-01

申办/合作机构-

100 项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的临床结果

登录后查看更多信息

100 项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的转化医学

登录后查看更多信息

100 项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的专利（医药）

登录后查看更多信息

110

项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的文献（医药）

2025-08-01·JOURNAL OF CONTROLLED RELEASE

Broadly active intranasal influenza vaccine with a nanocomplex particulate adjuvant targeting mast cells and toll-like receptor 9

Article

作者: Williamson, Grace L ; Staats, Herman F ; Lukesh, Nicole R ; Petrovsky, Nikolai ; Hendy, Dylan A ; Abraham, Mathew A ; Ashcraft, Kathleen A ; Ross, Ted M ; Bachelder, Eric M ; Murphy, Connor T ; Heise, Mark T ; Landon, Chelsea D ; Pena, Erik S ; Carlock, Michael ; Abraham, Soman N ; Ontiveros-Padilla, Luis ; Ainslie, Kristy M

Flumist is the only FDA-approved intranasal influenza vaccine. Although it has recently been approved for at-home use, it has significant limitations. These include reduced effectiveness in generating a protective immune response in patients with extensive influenza exposure, safety concerns due to its live attenuated virus formulation, and reduced efficacy due to viral drift/shift. To address this limitation, we have developed a nanocomplex comprised of a mast cell (MC) agonist and toll-like receptor 9 (TLR9) ligand to adjuvant a broadly acting influenza antigen. The newly reported MC agonist was identified by screening mastoparan-7 analogs for MC degranulation activity, which led to a more active peptide analog, MP12W. Positively charged MP12W spontaneously forms nanoparticulate complexes (NPs) with CpG 1826 that were then used to intranasally vaccinate mice with a computationally optimized broadly reactive antigen (COBRA) hemagglutinin (HA) protein. The NPs were further optimized by substituting CpG 1826 with CpG 55.2, a TLR-9 agonist identified by machine learning to be more active in humans. MP12W-CpG 1826 NPs showed an increased pro-inflammatory response and decreased cytotoxicity in vitro compared to M7 complexes, translating into a safer profile in a model of increased hypersensitivity, collaborative cross mice 027 (CC027). Intranasal vaccination with this complex and broadly reactive HA resulted in higher mucosal antibody concentration and increased cytokine production with antigen recall. These responses were enhanced with MP12W-CpG 55.2 NP vaccination. MP12W-CpG NPs provided similar protection in an influenza challenge model. This study demonstrates the potential of this novel intranasal nanocomplex for vaccination.

2024-01-01·Journal of immunology (Baltimore, Md. : 1950)

Distinct Functional Humoral Immune Responses Are Induced after Live Attenuated and Inactivated Seasonal Influenza Vaccination

Article

作者: Ross, Ted M ; Hanley, Hannah B ; Lingwood, Daniel ; Alter, Galit ; Carlock, Michael A ; Deng, Yixiang ; Tong, Xin ; McNamara, Ryan P ; Cizmeci, Deniz ; Fontana, Laura

Abstract:

Influenza viruses infect 5–30% of the world’s population annually, resulting in millions of incidents of hospitalization and thousands of mortalities worldwide every year. Although annual vaccination has significantly reduced hospitalization rates in vulnerable populations, the current vaccines are estimated to offer a wide range of protection from 10 to 60% annually. Such incomplete immunity may be related to both poor antigenic coverage of circulating strains, as well as to the insufficient induction of protective immunity. Beyond the role of hemagglutinin (HA) and neuraminidase (NA), vaccine-induced Abs have the capacity to induce a broader array of Ab effector functions, including Ab-dependent cellular cytotoxicity, that has been implicated in universal immunity against influenza viruses. However, whether different vaccine platforms can induce functional humoral immunity in a distinct manner remains incompletely defined. In this study, we compared vaccine-induced humoral immune responses induced by two seasonal influenza vaccines in Homo sapiens, the i.m. inactivated vaccine (IIV/Fluzone) and the live attenuated mucosal vaccine (LAIV/FluMist). Whereas the inactivated influenza vaccine induced superior Ab titers and FcγR binding capacity to diverse HA and NA Ags, the live attenuated influenza mucosal vaccine induced a more robust functional humoral immune response against both the HA and NA domains. Multivariate Ab analysis further highlighted the significantly different overall functional humoral immune profiles induced by the two vaccines, marked by differences in IgG titers, FcR binding, and both NK cell–recruiting and opsonophagocytic Ab functions. These results highlight the striking differences in Ab Fc-effector profiles induced systemically by two distinct influenza vaccine platforms.

2023-12-01·The Lancet. Child & adolescent health

Effectiveness of the quadrivalent live attenuated influenza vaccine against influenza-related hospitalisations and morbidity among children aged 2 to 6 years in Denmark: a nationwide cohort study emulating a target trial

Article

作者: Stensballe, Lone Graff ; Kildegaard, Helene ; Lund, Lars Christian ; Pottegård, Anton

BACKGROUND:

Scant evidence exists on the real-world effectiveness of quadrivalent live attenuated influenza vaccines (LAIV-4) in younger children. We aimed to assess the real-world effectiveness of LAIV-4 against influenza-related hospital contacts and admission and morbidity.

METHODS:

Using nationwide Danish health-care registries, we designed a cohort study that emulates a target trial, comparing LAIV-4 to no vaccination in children aged 2-6 years. Eligible children vaccinated from Oct 1, 2021, to Jan 15, 2022, were matched to unvaccinated controls in a 1:1 ratio according to demographic characteristics and risk groups for influenza, and followed-up until May 31, 2022. Primary study outcomes any hospital contact for influenza and influenza-related hospital admissions more than 12 h in duration, while hospital admission for respiratory tract infections, or for wheezing or asthma, and antibiotic prescriptions were evaluated as secondary outcomes. We estimated incidence rate ratios (IRRs) and 95% CIs using Poisson regression for each outcome. Vaccine effectiveness was calculated as 1 - IRR.

FINDINGS:

Among 308 520 Danish children aged 2-6 years, 95 434 vaccinated children were matched with 95 434 unvaccinated children who acted as controls. Receipt of LAIV-4 compared with no vaccination was associated with a reduced IRR of 0·36 (95% CI 0·27 to 0·46) and estimated vaccine effectiveness of 64·3% (53·6 to 72·6) against influenza-related hospital contacts (76 vs 210 events). The corresponding IRR and vaccine effectiveness against influenza-related hospital admissions were 0·63 (0·38 to 1·05) and 36·9% (-5·2 to 62·1; 24 vs 38 events), respectively. LAIV-4 was not associated with reductions in admission rates for respiratory tract infections (IRR 1·14, 95% CI 0·94 to 1·38), wheezing or asthma (1·04, 0·83 to 1·31), or antibiotic prescriptions for respiratory tract infections (0·97, 0·93 to 1·00). Vaccine effectiveness assessed across risk groups for influenza showed similar effectiveness in children with and without coexisting risk factors for severe influenza.

INTERPRETATION:

LAIV-4 offered moderate protection in younger children against influenza-related hospital contacts during a season dominated by influenza A(H3N2); however vaccination was not associated with reductions in secondary outcomes. This real-world study thereby supports trial evidence of moderate vaccine effectiveness of LAIV-4 against influenza-related outcomes when implementing broad vaccination schedules in younger children.

FUNDING:

Beckett-Fonden.

项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的新闻（医药）

2025-11-13

·生物制品圈

流感、新冠、RSV 通杀？黏膜疫苗凭啥成为防疫新宠

摘要：呼吸道感染一直是全球公共卫生的 “头号威胁”，从流感到新冠，再到呼吸道合胞病毒（RSV），每年都给人类健康带来巨大挑战。传统打针疫苗虽能降低重症风险，却难阻止病毒在呼吸道黏膜的初始感染和传播。而呼吸道黏膜疫苗的出现，彻底改变了这一局面 —— 通过鼻喷、雾化等无创方式，在病毒入侵的 “第一道防线”建立免疫屏障，既能诱导局部黏膜免疫，又能激活全身防护。本文将用通俗的语言，带你了解黏膜疫苗的工作原理、核心优势、技术突破，以及已经落地的临床应用，看看这款 “不用打针” 的疫苗如何成为防疫新主力。一、为啥我们需要黏膜疫苗？传统疫苗的 “短板” 很明显呼吸道疾病有多可怕？数据显示，慢性阻塞性肺疾病（COPD）、下呼吸道感染等一直是全球主要死因，2019 年导致约 250 万人死亡；新冠疫情更让我们见识到呼吸道病原体的威力，截至 2024 年底，全球累计确诊约 7.76 亿例，死亡超 700 万例。接种疫苗是预防感染最有效的方式，但传统疫苗大多是肌肉注射，存在明显 “短板”：人体呼吸道分上下两部分，下呼吸道靠血液里的 IgG 抗体保护，上呼吸道却依赖黏膜表面的分泌型 IgA（SIgA）抗体；肌肉注射疫苗只能诱导大量 IgG 抗体，很难刺激黏膜产生足够的 SIgA，就像 “大门没锁好”，病毒仍能通过呼吸道黏膜入侵；而且打针会让人紧张不适，尤其对儿童和老人来说，依从性不高。这时候，黏膜疫苗的优势就凸显了：它通过鼻喷、口服、雾化等方式给药，直接作用于呼吸道黏膜，既能诱导 SIgA 抗体形成局部防护，又能激活全身免疫，还能避免打针的痛苦，特别适合大规模免疫接种。二、黏膜疫苗的 “防御逻辑”：在病毒入侵口建 “防火墙” 要理解黏膜疫苗的作用，得先知道我们的呼吸道黏膜是如何 “防守” 的。呼吸道黏膜不只是简单的 “皮肤”，而是一套复杂的 “防御系统”。1. 呼吸道黏膜的三层防御网物理与上皮屏障：呼吸道表面覆盖着一层黏液，里面有黏蛋白、抗菌肽、SIgA 等物质，能像 “粘蝇纸” 一样困住病毒；黏膜上皮细胞紧密连接，形成物理屏障，还能通过纤毛摆动清除病原体；先天免疫组件：黏膜里藏着肺泡巨噬细胞、先天淋巴细胞（ILC）等 “哨兵”，能快速识别并攻击入侵的病毒；适应性免疫与黏膜记忆：一旦病毒突破前两道防线，黏膜相关淋巴组织（MALT）会启动 “精准反击”，产生 SIgA 抗体和组织驻留记忆 T 细胞（TRMs），这些细胞会长期驻扎在呼吸道，下次病毒再来时能立刻响应。2. 黏膜疫苗的工作流程（图 1）黏膜疫苗进入呼吸道后，会模拟病毒入侵的过程，激活黏膜免疫系统：疫苗中的抗原被黏膜中的树突状细胞识别并处理；树突状细胞将抗原呈递给 T 细胞和 B 细胞，激活它们并促使其增殖； B 细胞分化为浆细胞，产生大量 SIgA 抗体，通过 “免疫排斥” 机制阻止病毒黏附呼吸道细胞；同时诱导 TRMs 在呼吸道长期驻扎，形成 “免疫记忆”；激活的免疫细胞还会通过 “共同黏膜免疫系统”，迁移到其他黏膜组织，形成广泛保护。图1 | 呼吸道黏膜免疫机制示意图简单说，黏膜疫苗就是在病毒入侵的 “大门口” 建立起 “防火墙”，既不让病毒进门，又留下 “哨兵” 长期值守，比传统疫苗的防护更精准、更持久。三、黏膜疫苗的核心优势与技术挑战1. 三大核心优势，传统疫苗难替代双重免疫保护：既能诱导呼吸道局部的 SIgA 抗体，又能激活全身的 IgG 抗体和 T 细胞免疫，防护更全面；无创便捷：鼻喷、雾化等方式不用打针，大人小孩都容易接受，疫苗依从性大幅提升；阻断传播：能直接抑制病毒在呼吸道黏膜的复制，不仅能保护接种者，还能减少病毒传播给他人，特别适合疫情防控。2. 研发路上的 “拦路虎” 黏膜疫苗虽好，但研发难度不小：黏膜屏障的 “阻碍”：呼吸道黏膜的黏液、纤毛摆动会快速清除疫苗，导致疫苗停留时间短，吸收效率低；免疫耐受风险：黏膜系统的特点是 “耐受无害抗原”（比如食物蛋白），如果疫苗设计不当，可能诱导免疫耐受而非有效防护；安全隐患：鼻喷疫苗靠近中枢神经系统，可能引发鼻腔充血、短暂嗅觉丧失等局部反应，少数情况下存在神经安全风险；抗原稳定性：黏液中的蛋白酶、核酸酶可能破坏疫苗中的抗原，需要特殊递送系统保护。四、突破技术瓶颈：黏膜疫苗的 “升级装备” 为了应对这些挑战，科学家们开发了两大核心技术：黏膜佐剂和递送系统，让疫苗既能顺利到达目标细胞，又能有效激活免疫反应。1. 黏膜佐剂：给疫苗加 “助推器”（表 1）佐剂是疫苗的 “好帮手”，能增强抗原的免疫原性，让免疫系统更快、更强地响应。常用的黏膜佐剂有这些：类毒素佐剂：比如大肠杆菌不耐热毒素（LT）、霍乱毒素（CT）的衍生物，能增强黏膜通透性，激活局部免疫细胞，但需经过减毒处理保证安全；聚合物佐剂：比如壳聚糖，能黏附在黏膜表面，延长疫苗停留时间，还能保护抗原不被降解；多糖类佐剂：比如 β- 葡聚糖，能激活巨噬细胞和树突状细胞，促进 T 细胞反应；新型佐剂：比如 TLR 激动剂、细菌第二信使（c-di-AMP、c-di-GMP），能精准激活先天免疫信号通路，增强免疫反应。表1 常用黏膜疫苗佐剂 2. 递送系统：给疫苗装 “保护罩”（图 2）递送系统的作用是保护抗原穿过黏膜屏障，精准到达目标细胞，常用的有：纳米颗粒递送系统：比如纳米凝胶、聚合物纳米粒、无机纳米粒（金纳米粒、硅纳米粒），能包裹抗原，避免被酶降解，还能延长黏膜停留时间；自组装颗粒：比如铁蛋白纳米粒、SpyCatcher/SpyTag 系统，能有序展示抗原，增强免疫激活；病毒载体：比如腺病毒、新城疫病毒（NDV），能高效递送抗原基因，诱导强烈免疫反应；免疫刺激复合物（ISCOMs）：由抗原、胆固醇、磷脂和皂素组成，能有效激活 CD8+T 细胞反应。图 2 | 黏膜疫苗佐剂与递送系统五、已落地的黏膜疫苗：流感、新冠、RSV 都能防经过多年研发，多款呼吸道黏膜疫苗已经获批上市或进入临床试验，覆盖流感、新冠、RSV 等主要呼吸道病毒。1.流感黏膜疫苗 FluMist（鼻喷流感减毒活疫苗）：2003 年获批，是全球应用广泛的鼻喷流感疫苗，能诱导两倍于传统疫苗的 SIgA 抗体，对儿童的保护率高达 90%； Nasovac-S：印度研发的三价鼻喷减毒活疫苗，保护率近 80%，适合 2 岁以上人群，局部反应轻微； M2SR：采用 “单轮复制” 技术的鼻喷疫苗，只能在接种部位复制一次，安全性高，还能提供跨亚型保护，对不同流感毒株都有效。2.新冠黏膜疫苗 Convidecia Air（雾化新冠疫苗）：全球首款获批的新冠黏膜疫苗，通过雾化吸入给药，作为加强针时，中和抗体水平比传统灭活疫苗高 7.8 倍，对奥密克戎变异株也有良好保护； Sputnik V（鼻喷版）：俄罗斯获批的腺病毒载体鼻喷疫苗，能诱导持久的黏膜 IgA 和 T 细胞反应，完全保护接种者不发生重症； BBV154：印度获批的鼻喷新冠疫苗，采用 chimpanzee 腺病毒载体，中和抗体水平优于传统肌肉注射疫苗，安全性良好。3.RSV 黏膜疫苗 RSVt：赛诺菲研发的减毒活疫苗，进入 III 期临床试验，在 6-24 个月婴儿中耐受性良好，能诱导强烈的中和抗体反应； BLB201：采用副流感病毒 5 型（PIV5）为载体的鼻喷疫苗，I 期临床试验显示，能诱导 RSV 特异性 IgA 和 T 细胞反应，无严重不良反应。六、未来展望：黏膜疫苗将成为防疫 “主力军” 呼吸道黏膜疫苗的发展，正在改变疫苗研发的格局。未来，它还将在这几个方向突破：多病原体联合疫苗：一款疫苗同时预防流感、新冠、RSV 等多种呼吸道病毒，减少接种次数；长效保护技术：通过优化佐剂和递送系统，延长黏膜记忆细胞的存活时间，让疫苗保护期更长；个性化疫苗：根据不同人群的免疫背景（比如儿童、老人、已接种过疫苗的人），设计针对性的疫苗策略；更多疾病覆盖：除了病毒感染，还将应用于细菌感染（如百日咳）、 mucosal 肿瘤等疾病的预防和治疗。从打针到鼻喷，黏膜疫苗不仅让接种更便捷，更在病毒入侵的 “第一道防线” 建立了坚固的免疫屏障。随着技术的不断进步，相信这款 “无创、高效、广谱” 的疫苗，会成为未来公共卫生防疫的 “主力军”，守护我们的呼吸健康。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗临床研究

2025-10-24

·生物制品圈

新一代流感减毒活疫苗：合成生物学带来的防疫革命

摘要:流感每年造成全球上亿人感染、数十万人死亡，传统疫苗常面临效果不稳定、研发滞后等问题。流感减毒活疫苗（LAIV）因能激发全面免疫反应备受关注，但传统开发方式存在安全隐患。随着合成生物学的发展，科学家通过精准基因改造技术，打造出更安全、有效的新一代 LAIV。本文将带你了解流感疫苗的现状、新型疫苗的研发黑科技，以及未来防疫的新可能。推荐阅读：美国两款"亚单位"流感疫苗退市,一场疫苗技术暗战浮出水面一、流感的威胁：不止是普通感冒每年秋冬季节，流感总会准时 “报到”，但它绝不是简单的感冒。根据世界卫生组织数据，全球每年因季节性流感导致约 10 亿人感染，300 万至 500 万重症病例，29 万至 65 万人死亡。而甲型流感病毒引发的大流行更具毁灭性，1918 年的流感大流行造成了超过 4000 万人死亡。流感病毒家族主要分为甲、乙、丙、丁四型，其中甲型（IAV）和乙型（IBV）流感病毒是人类季节性流感的主要元凶。甲型流感病毒宿主广泛，可在鸟类、猪、人类等物种间传播，还能跨物种重组产生新毒株；乙型流感病毒主要感染人类，虽不引发大流行，但每年也会造成大量病例。这些病毒通过表面的血凝素（HA）和神经氨酸酶（NA）入侵人体细胞，且极易发生变异，让疫苗研发始终处于 “追赶” 状态。二、疫苗双雄：传统流感疫苗的优势与短板目前主流的流感疫苗主要有两种：灭活流感疫苗（IIVs）和活减毒流感疫苗（LAIVs）。灭活疫苗是大家最熟悉的类型，通过注射接种，安全性较高，能有效应对匹配的病毒毒株。但它也有明显缺点：只能激发体液免疫，对老年人等易感人群保护效果有限，且生产依赖鸡蛋，一旦遭遇禽流感疫情导致鸡蛋供应中断，就可能出现疫苗短缺。流感减毒活疫苗则采用鼻腔喷雾接种，模拟自然感染过程，既能激发体液免疫，又能诱导细胞免疫和黏膜免疫，交叉保护效果更优。比如常见的 FluMist 疫苗，通过低温适应技术减弱病毒毒性，让其仅能在呼吸道上部复制。但传统 LAIV 的研发依赖经验摸索，效果不稳定，曾在 2013-2014 季因对甲型 H1N1 毒株保护效果差被暂停使用。此外，它还存在毒力返强的风险，目前仅推荐 2-49 岁健康人群接种。三、黑科技登场：合成生物学重构疫苗研发面对传统疫苗的困境，合成生物学和基因工程技术带来了突破性解决方案。科学家通过精准改造病毒基因组，实现对疫苗的 “量身定制”，主要有以下核心技术路径：（一）反向遗传学技术：疫苗生产的 “精准操控台” 传统疫苗生产依赖鸡蛋培养，容易产生变异影响效果。反向遗传学技术的出现改变了这一现状，它通过构建病毒基因组的质粒载体，在细胞中直接合成病毒。如图 1 所示，研究人员将流感病毒的 8 个基因片段分别克隆到质粒中，转染细胞后就能产生完整病毒。这种方法不仅摆脱了对鸡蛋的依赖，还能精准插入突变位点，快速构建减毒毒株，为疫苗研发按下 “加速键”。（二）基因改造策略：给病毒 “戴上紧箍咒” 科学家通过多种基因修饰方式减弱病毒毒性，同时保留其免疫原性，主要包括： NS1 基因缺失/截短：NS1 蛋白是病毒的 “免疫逃逸工具”，能抑制人体干扰素反应。删除或截短该基因后，病毒在人体中复制能力大幅下降，但仍能激发强烈免疫反应。这类疫苗已在多种动物模型中验证有效，部分进入临床 trials。 M2 蛋白缺陷改造：M2 蛋白对病毒组装至关重要，破坏其胞质尾结构会导致病毒无法正常复制。研究人员开发的 M2SR 疫苗，只能在特定细胞中完成单次复制，安全性大幅提升，且能激发广谱保护，目前已进入临床阶段。基因组重排：通过调整病毒基因片段的排列顺序，或插入外来基因，既能减弱病毒复制能力，又能实现多价疫苗设计。如图 5 所示，科学家通过重排技术构建出同时表达 H1 和 H3 亚型 HA 蛋白的疫苗，可同时应对多种毒株。密码子优化：利用生物密码子的偏好性，将病毒基因替换为低效密码子，降低其蛋白质合成效率，实现减毒。这种方法不会改变病毒蛋白结构，且毒力返强风险极低，已应用于多种病毒疫苗研发。（三）智能调控技术：给疫苗加 “安全锁” 为进一步提升安全性，科学家开发了多种条件性减毒技术： microRNA 调控：在病毒基因组中插入特定 microRNA 识别序列，让病毒在人体组织中因 RNA 降解而无法复制，但在疫苗生产系统中正常生长。小分子控制：将依赖药物激活的蛋白片段插入病毒基因，只有在特定药物存在时病毒才能复制，避免疫苗在人体内失控。蛋白降解靶向：通过改造病毒蛋白，使其在人体细胞中被泛素 - 蛋白酶体系统降解，实现精准减毒。四、新一代疫苗的优势与挑战如表 1 所示，新型流感减毒活疫苗在安全性、广谱性和生产效率上都有显著提升：它们毒力返强风险低，部分能应对多种变异毒株，且细胞培养生产模式更灵活。比如 PROTAR 2.0 疫苗平台，可在病毒多个位点插入减毒模块，同时针对多种 E3 连接酶实现精准调控，在动物实验中展现出全面的交叉保护效果。但这些新技术仍面临挑战：部分疫苗生产依赖特殊细胞系，增加了生产成本；病毒重组的潜在风险需要长期监测；临床转化和监管审批也需要时间。此外，针对丙型和丁型流感病毒的疫苗技术仍在探索中。五、未来展望：流感防疫进入精准时代随着技术的不断成熟，新一代流感减毒活疫苗有望解决传统疫苗的诸多痛点。未来，疫苗研发将更快速灵活，能在新毒株出现后迅速设计生产匹配疫苗；通过表达保守抗原，还可能开发出 “通用流感疫苗”，一劳永逸地应对流感变异。在生产方面，细胞培养和生物反应器技术将取代鸡蛋培养，实现大规模标准化生产，同时热稳定的制剂的研发将减少疫苗对冷链的依赖，更便于全球分发。针对不同人群的定制化疫苗也将出现，为老年人、儿童等易感群体提供更精准的保护。从经验摸索到精准设计，流感疫苗的发展见证了生物技术的进步。虽然挑战仍在，但这些创新技术正在为人类战胜流感带来新的希望。未来，当我们再次面对流感威胁时，或许能拥有更强大的防疫武器，让流感季不再成为困扰。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

2025-10-10

·Pharmaceutical Technology

Flu vaccine uptake increases 28% in England

There are currently seven licensed flu vaccines available for the 2025 to 2026 season. Tong_stocker via Shutterstock.com. The number of people receiving a flu vaccine across England has increased by over a quarter, as cases of both influenza and Covid-19 start to climb at the start of the viral season. Data from England’s National Health Service (NHS) shows that the flu jab has been administered to 4.3 million people, a 28% rise from 3.36 million who received the vaccine at the same point last year. The vaccination drive comes as the flu season commences. Influenza infections start to uptick around October, with peaks usually coming in December. Vaccines can help protect against the flu and are offered to people every year at higher risk of becoming seriously ill. Caused by the influenza virus, flu is significantly more serious than the common cold, which is caused by a wide range of viruses. The UK Health Security Agency’s (UKHSA’s) latest surveillance data showed that flu positivity increased from 1.9% to 3.3% and Covid-19 positivity in hospital settings increased from 11.7% in the previous week to 12.9%. One of the key changes to this year’s vaccine programme is the switch from quadrivalent (QIV) to trivalent (TIV) vaccines in inactivated influenza vaccines (IIV). The World Health Organization (WHO) recommends the composition of influenza vaccine strains each year based on global virus trends. For the 2025/26 season, WHO recommends the use of the trivalent vaccine for the Northern Hemisphere. This is because the influenza B/Yamagata lineage virus has not been detected worldwide since 2020 and is not predicted to cause future epidemics. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence There are currently seven licensed flu vaccines available for the 2025 to 2026 season. CSL Seqirus’ cell-based quadrivalent influenza vaccine, Sanofi’s Vaxigrip, and Viatris’ Influenza vaccine TIV MYL are given to those above six months of age. AstraZeneca’s Fluenz Tetra, a live attenuated influenza vaccine (LAIV), is for those between two and 18 years of age. For adults over 18 years of age, Sanofi’s Supemtek, a recombinant trivalent influenza vaccine, is used. CSL Seqirus’ other adjuvanted trivalent influenza vaccine is licensed for use for adults above 50 years of age. Sanofi’s Efluelda TIV-HD is available to those 60 years of age and over. The NHS offers flu vaccines for everyone aged 65 and over, and for adults 18 to 64 years of age in certain risk groups. The NHS is bracing itself for a busy winter. Regional teams are improving access to the vaccines through mobile vaccination buses, family community drop-in sessions, and, in an NHS first, delivering flu vaccines to two and three-year-olds in community pharmacies. Meanwhile, eligibility for the Covid-19 vaccine changed for this autumn and winter following an update on recommendations by the Joint Committee on Vaccination and Immunisation (JCVI). The committee advises that the vaccines be offered to people aged 75 or over, residents in care homes, or anyone with a weakened immune system. Dr Amanda Doyle, national director for Primary Care and Community Services at NHS England, said : “Vaccination is a crucial part of our efforts to protect the vulnerable and prepare for what we expect to be a very challenging winter, so I’m delighted to see this big increase in the numbers of people getting vaccinated at this stage. “Vaccinations are our best defence against these potentially very dangerous viruses and can genuinely save lives.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

疫苗上市批准

100 项与 Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB03	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
流感病毒感染	欧盟	AstraZeneca AB	2013-12-04
流感病毒感染	冰岛	AstraZeneca AB	2013-12-04
流感病毒感染	列支敦士登	AstraZeneca AB	2013-12-04
流感病毒感染	挪威	AstraZeneca AB	2013-12-04
甲型流感病毒感染	美国	MedImmune LLC	2003-06-17
乙型流感病毒感染	美国	MedImmune LLC	2003-06-17

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
流感样症状	临床3期	日本	AstraZeneca PLC	2014-10-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03101462 (CTgov)	临床4期	流感病毒感染	38	IIV (Inactivated Influenza Vaccine (IIV))	廠製齋鑰範齋顧鑰範範(廠廠衊襯窪夢顧構築齋) = 選獵鏇遞窪淵製觸範壓襯願網選襯齋鹽願鹽窪 (艱願範鹽簾鏇艱顧窪夢, 簾鹽範壓淵鹹蓋鹽遞簾 ~ 鹹積繭構積簾構壓觸積) 更多	-	2019-03-06
				LAIV (Live Attenuated Influenza Vaccine (LAIV))	廠製齋鑰範齋顧鑰範範(廠廠衊襯窪夢顧構築齋) = 夢壓觸願築膚築鑰鑰餘襯願網選襯齋鹽願鹽窪 (艱願範鹽簾鏇艱顧窪夢, 壓觸選艱積構願願齋廠 ~ 鹽繭蓋鏇顧憲顧繭膚構) 更多
NCT03028974 (CTgov)	临床4期	流感病毒感染	77	FluMist® (Group A: 2-4 yo LAIV4 (Return))	壓淵鹽鬱築鏇範鬱艱憲 = 糧廠鏇糧網窪蓋製夢艱獵糧築淵製選遞積糧願 (製獵淵簾範鏇觸鹽積齋, 膚膚製膚積顧繭壓廠構 ~ 鏇積獵窪遞淵廠鹽網簾) 更多	-	2018-12-14
				Fluzone® (Group E: 6 - 23 Mos Old IIV4 (Single Yr))	廠壓製顧膚餘蓋鏇齋憲 = 鹽簾餘製壓廠醖憲積選廠網淵醖鹹範廠網築壓 (壓遞鑰醖遞遞鏇觸餘遞, 範夢顧繭遞願鏇獵艱製 ~ 鹽鏇鏇獵衊簾繭糧壓壓) 更多
NCT03143101 (FluMist, CTgov)	临床4期	流感病毒感染	200	FluMist trivalent (FluMist Trivalent (2015-2016))	繭壓齋鏇鹹齋廠願範範 = 願繭獵遞鏇糧餘鑰構鹹範齋築夢鬱齋壓淵淵製 (願壓積艱鑰鑰鬱夢範鹹, 獵簾積壓獵淵繭餘襯鏇 ~ 簾願廠壓積蓋鬱鑰構積) 更多	-	2018-12-11
				FluMist Quadrivalent (FluMist Quadrivalent (2015-2016))	繭壓齋鏇鹹齋廠願範範 = 齋願構淵艱憲鑰廠淵齋範齋築夢鬱齋壓淵淵製 (願壓積艱鑰鑰鬱夢範鹹, 製襯艱製衊窪繭觸廠醖 ~ 餘鏇窪鑰選糧夢襯衊選) 更多
NCT02474901 (QLAIV, CTgov)	临床2期	HIV感染 \| 流感病毒感染	101	Quadrivalent Live Attenuated Influenza Vaccine (QLAIV, HIV-infected)	膚夢鏇齋窪壓艱廠鹹憲 = 鹹憲繭繭齋衊鹽願餘範衊壓顧艱窪膚醖鬱齋淵 (膚鑰夢鬱製構蓋顧鑰鏇, 觸窪窪窪窪網築憲顧艱 ~ 遞範糧製簾獵選蓋製夢) 更多	-	2017-10-16
				Quadrivalent Live Attenuated Influenza Vaccine (QLAIV, HIV-uninfected)	膚夢鏇齋窪壓艱廠鹹憲 = 繭獵壓積觸簾選鹽鹽繭衊壓顧艱窪膚醖鬱齋淵 (膚鑰夢鬱製構蓋顧鑰鏇, 夢夢鬱夢膚壓鹹鹹蓋鏇 ~ 築築範製夢鬱範餘範衊) 更多
NCT03028987 (CTgov)	临床4期	流感病毒感染	10	FluMist® (LAIV Randomized)	繭簾餘顧網範簾獵醖膚 = 遞築築蓋遞鏇範艱願衊獵糧選範夢積膚衊糧餘 (餘鹹淵齋窪觸鏇網積顧, 繭憲繭衊鏇積窪鹽餘憲 ~ 遞淵鹹糧憲鏇艱淵繭願) 更多	-	2017-09-12
				Fluzone® (IIV4 Randomized)	繭簾餘顧網範簾獵醖膚 = 膚襯顧膚鑰廠鹹選鏇廠獵糧選範夢積膚衊糧餘 (餘鹹淵齋窪觸鏇網積顧, 網餘醖簾選顧遞窪鏇壓 ~ 簾糧獵齋鹽網鹽顧廠醖) 更多
NCT01933048 (SNIF, CTgov)	临床4期	流感病毒感染	1,077	FluMist (Healthcare Worker Administration)	鏇蓋蓋積鹽構積製壓齋(遞糧鹹顧淵襯鬱觸壓廠) = 壓選淵窪範窪廠選觸艱鹹遞窪範醖淵獵鹽網範 (顧遞願衊蓋願積艱鹹積, 鑰膚糧簾選襯願獵淵齋 ~ 憲餘齋範襯襯糧鏇窪壓) 更多	-	2017-09-12
				FluMist (Self-Administration)	鏇蓋蓋積鹽構積製壓齋(遞糧鹹顧淵襯鬱觸壓廠) = 願憲鹽襯網衊獵網積餘鹹遞窪範醖淵獵鹽網範 (顧遞願衊蓋願積艱鹹積, 顧鏇襯範築選艱鬱膚蓋 ~ 築鹽衊網淵願襯觸鬱選) 更多
NCT02141581 (CTgov)	临床4期	流感病毒感染	86	Fluzone	鑰襯蓋範鏇糧製選醖製 = 糧壓構壓鬱鏇構鑰醖範觸糧積醖選觸製夢範膚 (鏇鑰鹽鏇壓顧繭餘鏇鑰, 繭願鹹衊願憲廠艱願憲 ~ 艱鹽鬱簾簾積鹽獵夢衊) 更多	-	2017-05-11
NCT03023709 (CTgov)	临床4期	流感病毒感染	3	Fluzone® (Pilot Phase)	鑰夢淵網壓蓋築壓鏇範 = 鏇構選願築觸鹽蓋觸鹽構膚衊願簾鹹壓壓觸積 (廠齋選餘壓餘製簾艱繭, 鑰襯餘憲艱糧壓願繭夢 ~ 選糧淵製糧選遞衊醖餘)	-	2017-05-10
				FluMist® (Study Phase)	鑰夢淵網壓蓋築壓鏇範 = 艱鏇艱齋壓簾憲製鏇窪構膚衊願簾鹹壓壓觸積 (廠齋選餘壓餘製簾艱繭, 夢餘遞鹽鑰簾構願製窪 ~ 網鏇壓鬱選壓衊壓膚製)
NCT02133781 (CTgov)	临床4期	流感病毒感染	51	Fluzone+FluMist (Age 8-17 Years (Identical Twins ))	鬱齋廠艱夢膚廠蓋顧夢 = 壓鹹糧網簾憲廠艱艱壓艱糧遞顧獵選製顧醖夢 (夢淵繭選獵醖壓鹹艱繭, 淵醖鹽醖積醖鬱憲願範 ~ 艱獵鬱繭願遞餘鏇膚獵) 更多	-	2017-03-10
				Fluzone (Age 18-30 Years (Non-twins))	鬱齋廠艱夢膚廠蓋顧夢 = 糧構網鏇窪獵淵獵範蓋艱糧遞顧獵選製顧醖夢 (夢淵繭選獵醖壓鹹艱繭, 觸遞衊糧遞淵齋願選構 ~ 齋艱遞積夢廠積糧餘艱) 更多
NCT03023553 (CTgov)	临床4期	流感病毒感染	13	FluMist®	鹽艱繭築獵鹹遞廠餘網 = 鹹選壓壓範淵衊範糧願鹽憲顧夢顧襯積淵蓋夢 (簾衊鑰艱鹹簾鏇窪蓋鏇, 觸蓋繭淵積願範廠鑰壓 ~ 餘觸獵餘鏇顧鏇夢築獵) 更多	-	2017-03-09