A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a SARS CoV 2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Participants ≥ 50 Years of Age

The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant.

开始日期2024-08-30

申办/合作机构

Novavax, Inc.

NCT05648357 / Recruiting临床4期

A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

开始日期2023-12-14

申办/合作机构

GSK Plc

NCT05734040 / Completed临床2期

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

开始日期2023-05-10

申办/合作机构

Osivax SAS初创企业

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100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的专利（医药）

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项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的文献（医药）

2023-10-12·Vaccines

Immunogenicity and Safety of One versus Two Doses of Quadrivalent Inactivated Influenza Vaccine (IIV4) in Vaccine-Unprimed Children and One Dose of IIV4 in Vaccine-Primed Children Aged 3-8 Years.

Article

作者: Li, Lanshu ; Tang, Rong ; Wang, Jianfeng ; Pan, Hongxing ; Yang, Wanqi ; Shi, Yunfeng ; Hu, Yuansheng ; Chu, Kai ; Zhao, Chenyan ; Li, Xiaoyu ; Xu, Li

Two doses of the inactivated influenza vaccine (IIV) are generally recommended for children under 9 years old. This study assessed the necessity for a second dose of quadrivalent IIV (IIV4) in children aged 3-8 years. In this randomized, open-label, paralleled-controlled study, 400 children aged 3-8 years who were vaccine-unprimed were randomly assigned at a 1:1 ratio to receive a two-dose (Group 1) or one-dose (Group 2) regimen of IIV4, and 200 who were vaccine-primed received one dose of IIV4 (Group 3). A serum sample was collected before and 28 days after the last dose to determine the hemagglutination inhibition (HI) antibody level. Adverse events were collected within 28 days after each dose. One-dose or two-doses of IIV4 were well tolerated and safe in children aged 3-8 years, and no serious adverse events related to the vaccine were reported. The seroconversion rates (SCRs) of HI antibody ranged from 61.86% to 95.86%, and the post-vaccination seroprotection rates (SPRs) were all >70% in three groups against the four virus strains. The two-dose regimen in vaccine-unprimed participants (Group 1) achieved similar SPRs in comparison with the one-dose in the vaccine-primed group (Group 3), and the SPRs in Group 1 and Group 3 were higher in vaccine-unprimed participants of the one-dose regimen (Group 2). The present study supports the recommendations of a two-dose regimen for IIV4 use in children aged 3-8 years.

2023-09-26·Vaccines

Immunogenicity and Safety of MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared with a Nonadjuvanted, Quadrivalent Influenza Vaccine in Adults 50-64 Years of Age.

Article

作者: Versage, Eve ; Zhang, Qiuhong ; Molrine, Deborah ; Meyer, Jay ; Hohenboken, Matthew ; Poder, Airi ; Heymer, Peter ; Oberije, Janine ; Isakov, Leah

Adults aged 50-64 years have a high incidence of symptomatic influenza associated with substantial disease and economic burden each year. We conducted a randomized, controlled trial to compare the immunogenicity and safety of an adjuvanted quadrivalent inactivated influenza vaccine (aIIV4; n = 1027) with a nonadjuvanted standard dose IIV4 (n = 1017) in this population. Immunogenicity was evaluated on Days 22, 181, and 271. On Day 22, upper limits (UL) of 95% confidence intervals (CI) for geometric mean titer (GMT) ratios (IIV4/aIIV4) were <1.5 and 95% CI ULs for the difference in seroconversion rate (SCR IIV4 - aIIV4) were <10% for all four vaccine strains, meeting primary endpoint noninferiority criteria. Protocol-defined superiority criteria (95% CI ULs < 1.0) were also met for A(H1N1) and A(H3N2). Immune responses following aIIV4 vaccination were more pronounced in persons with medical comorbidities and those not recently vaccinated against influenza. Safety data were consistent with previous studies of MF59 adjuvanted seasonal and pandemic influenza vaccines. These findings support the immunological benefit of aIIV4 for persons aged 50-64 years, especially those with comorbidities.

2023-08-01·Open forum infectious diseases

Additional Burden Averted in the United States From Use of MF59-Adjuvanted Seasonal Influenza Vaccine Compared With Standard Seasonal Influenza Vaccine Among Adults ≥65 Years.

Article

作者: Haag, Mendel ; Sardesai, Aditya ; Toro-Diaz, Hector ; Taylor, Alexandra ; McGovern, Ian

Background:

The MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) is designed to overcome immunosenescence and enhance vaccine responses in older adults. We expanded on the Centers for Disease Control and Prevention (CDC) modeling method to estimate the number of additional influenza-related outcomes averted with aIIV3 versus generic quadrivalent inactivated influenza vaccine (IIV4) in adults ≥65 years over 3 influenza seasons (2017-2018 to 2019-2020) in the United States.

Methods:

A static compartmental model was developed based on an existing CDC model with 2 previously recommended calculation methods that increased the accuracy of the model in providing estimates of burden averted. Model inputs included vaccine effectiveness, vaccine coverage, population counts, and disease burden estimates. Additional burden averted (symptomatic cases, outpatient visits, hospitalizations, intensive care unit [ICU] admissions, and deaths) was expressed as total incremental cases averted between the vaccines. Sensitivity analyses tested the resilience of the model results to uncertainties in model inputs.

Results:

The model estimated that vaccination with aIIV3 versus IIV4 would avert 2.24 times as many symptomatic cases, outpatient visits, hospitalizations, ICU stays, and deaths during 2017-2018; the burden averted in 2018-2019 and 2019-2020 with aIIV3 would be 3.44 and 1.72 times that averted with IIV4, respectively. Disease burden estimates and relative vaccine effectiveness of aIIV3 had the greatest impact on model estimates.

Conclusions:

Over 3 influenza seasons, the model estimated that aIIV3 was more effective than IIV4 in averting influenza-related outcomes, preventing 1.72 to 3.44 times as many influenza illnesses with proportionate decreases in related healthcare use and complications.

项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的新闻（医药）

2024-04-24

·生物制品圈

剂型升级！百克生物液体流感疫苗申报上市，适用人群有望扩至3-59岁

2024年4月24日，据国家药品监督管理局药品审评中心显示，长春百克生物科技股份公司的鼻喷流感减毒活疫苗申报上市并获受理，受理号为CXSS2400043。而据公司投资者关系记录，截至2023年12月，公司的液体流感疫苗已处于Pre-NDA阶段。由此推测，本次申报的流感疫苗很可能是剂型升级后的液体剂型鼻喷流感减毒活疫苗。表1：百克生物鼻喷流感减毒活疫苗申报上市并获受理2020年，百克生物的冻干鼻喷流感减毒活疫苗获批上市。该款疫苗是纳入WHO全球流行性流感行动计划的、国内独家经鼻喷接种的流感减毒活疫苗，产品具有生产效率高、依从性高、可诱导三重免疫等优势，新流感疫苗预防接种技术指南发布后，该产品针对3-8岁儿童的依从性优势更为突出。图1：鼻喷流感疫苗作用机理而鼻喷流感减毒活疫苗是在冻干鼻喷流感减毒活疫苗的基础上增加的液体剂型。流感疫苗接种期工作量繁重，公司此前上市的冻干剂型流感疫苗需要复溶过程，增加了工作投入成本，而鼻喷流感减毒活疫苗（液体剂型）若是顺利上市，则将大幅提升接种便利性，且该产品有望进一步将适用人群扩大至3-59周岁，届时公司流感疫苗渗透率有望大幅提升。另外，公司还计划在2024年申报佐剂流感疫苗的临床研究，该疫苗适用人群为6月龄及以上人群，重点覆盖60岁以上及3岁以下人群，与鼻喷剂型相配合，进而可实现流感疫苗产品组合的全人群覆盖。据WHO数据显示，全球每年由于流感导致重症人数约为300万-500万，死亡人数约为29万-65万，其中儿童罹患率和感染率最高。而从流感疫苗渗透率看，目前我国流感疫苗整体接种率仅为4%左右，与美国以及WHO建议的流感疫苗目标接种率75%相差甚远，国内流感疫苗渗透率有较大的提升空间。图2：中美流感疫苗接种率目前有三种类型的流感疫苗，即“灭活”、“减毒活疫苗”和“重组HA”疫苗，在不同国家被许可供人使用。根据包含的流感病毒类型，流感疫苗分为三价和四价，三价流感疫苗里包括了甲型H1H1、甲型H3N2和乙型Victoria三种流感病毒的类型，可以预防这三种流感病毒感染。四价流感疫苗比三价多包括了乙型Yamagata流感病毒。关于流感疫苗价次，在2024年3月FDA的VRBPAC会议上，FDA宣布2024-2025年流感季节在美国只使用三价流感疫苗。实际上，去年世界卫生组织流感疫苗咨询委员会就提出“不再需要在流感疫苗中加入B/Yamagata系抗原”的观点。在2024年2月23日发布的北半球流感疫苗推荐毒株，对比上次2024年南半球，世卫组织进一步决定流感疫苗回归三价。也就是说，目前的现状是四价流感疫苗接种的必要性降低了，性价比也不如三价流感疫苗高。据《中国流感疫苗预防接种技术指南（2023-2024）》显示，我国批准上市的流感疫苗包括三价灭活疫苗(IIV3)、三价减毒活疫苗(LAIV3)和四价灭活疫苗(IIV4)。对可接种不同类型、不同厂家疫苗产品的人群，可自愿接种任何一种流感疫苗，无优先推荐。其中，LAIV3仅百克生物一家。基于国内有部分企业只有四价流感疫苗，没有三价流感疫苗生产许可，因此推测性价比更高的三价流感疫苗很可能会出现缺货现象。表2：我国上市流感疫苗类型表3：2022-2023国内批签发的流感疫苗厂家一览据中检院披露的生物制品批签发情况显示，2023年国内裂解及冻干鼻喷流感疫苗批签发331批次。其中流感病毒裂解疫苗共批签发324批次。基于国内有部分企业只有四价流感疫苗，没有三价流感疫苗生产许可，因此推测性价比更高的三价流感疫苗很可能会出现缺货现象。图3：2023年国内流感病毒裂解疫苗各企业批签发份额-批次数，2023年批签发数据统计时间段为2023.01.02-2023.12.31参考资料：[1]【百克生物|公司深度】百战克疫稳增长，带疱疫苗再争锋【国投证券医药马帅团队】.医药马帅团队.2024-01-08.[2]百克生物-688276-公司深度报告：带疱疫苗市场潜力巨大，看好公司长期发展.东北证券.2024-04-21.[3]盘点2023年流感疫苗市场.生物制品圈.2024-04-05.[4]四价流感疫苗要被淘汰了？.预防界.2024-04-23.[5]国家药品监督管理局药品审评中心官网.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点，不代表本站立场。

疫苗临床研究

2024-04-05

·生物制品圈

盘点2023年流感疫苗市场

流感是一种上呼吸道急性传染病，由流感病毒引起，主要通过感染者的飞沫或呼吸道分泌物传播。流感病毒属于正粘病毒科，基因组为单链RNA。流感大流行是目前公共卫生领域主要问题之一。季节性流感（甲型和乙型流感亚型）极大地威胁着全球公共卫生并影响全球经济。因此，必须将流感样疾病监测和相关疫苗接种作为预防和控制流感的策略。图1 甲型流感病毒颗粒及其组分的结构示意图流感病毒属于正粘病毒科，是单股、负链、分节段的RNA病毒。根据病毒核蛋白和基质蛋白，分为甲、乙、丙、丁（或A、B、C、D）四型。甲型流感病毒：根据病毒表面的血凝未（HA）和神经氨酸酶（NA）的蛋白结构和基因特性，可分分为多种亚型。目前，发现的HA和NA分别有18个（H1-18）和11个（NI-11）亚型。甲型流感病毒宿主众多，除感染人外，在动物中广泛存在，如禽类、猪、马、海豹以及鲸鱼和水貂等。乙型流感病毒：根据HA基因型分为Victoria系和Yamagata系，既往多个流行季在人群中交替流行或混合流行。2020年3月至今，全球几乎未再监测到自然流行的乙型Yamagata系流感病毒株，引起流感季节性流行的病毒主要是甲型流感病毒中的HINI、H3N2亚型及乙型流感病毒中的Victoria系。丙型流感病毒：可感染人、狗和猪，仅导致上呼吸道感染的散发病例。丁型流感病毒：主要感染猪、牛等，尚未发现感染人。因此，甲型和乙型流感病毒是人类监测的主要对象。而据上图Nature子刊发表的文章称，从2020年4月-2021年8月，全球范围内没有再分离出乙型流感病毒B/Yamagata谱系毒株，这意味着该谱系的病毒毒株可能已经灭绝。究其原因，B/Yamagata系的“消失”很大程度与新冠疫情的防控措施——特别是改变生活行为、佩戴口罩以及增加社交距离、外出限制等有关。这些措施对于防控呼吸道传染病都具有同样的效果，所以呼吸道疾病发病数量的减少是突出的表现。那B/Yamagata系的“消失”对疫苗接种有何影响呢？WHO最新发布的南半球三价疫苗推荐中包含的是H3N2、甲型H1N1和BV组分，不含有BY组分。不过处于谨慎起见，WHO今年还是继续提供了4价流感疫苗的组份推荐。具体流感病毒毒株推荐如下：图2 2024—2025年北半球季节性流感疫苗WHO推荐组分那我们到底应该选3价还是4价呢？据《中国流感疫苗预防接种技术指南（2023-2024）》显示，我国批准上市的流感疫苗包括三价灭活疫苗(IIV3)、三价减毒活疫苗(LAIV3)和四价灭活疫苗(IIV4)。对可接种不同类型、不同厂家疫苗产品的人群，可自愿接种任何一种流感疫苗，无优先推荐。另外，美国儿科学会对此的意见亦是无优先推荐。也就是说，打3价和4价都行。1.流感疫苗是应对流感的最佳手段季节性流感全球每年的发病率估计为成人5-10%，儿童为20-30%，导致数百万美元用于疫苗接种计划和患者治疗。虽然大多数感染流感的人症状轻微，康复后无后遗症，但有些人可能会发展为严重疾病，特别是那些患有高风险疾病的人（例如，老年人，孕妇和幼儿）。根据世界卫生组织（WHO）的数据，全球季节性流感流行每年估计造成300万至500万例重症病例和30万至65万人死亡。中国南方省份已现流感抬头趋势。国家流感中心数据显示南方门急诊流感样病例占比ILI% 3.0%(5/16~5/22)快速上升至6.8%(6/13~6/19)，高于2019-2021年同期水平(4.2%、3.1%、4.3%)，流感阳性检出率达23%且以A(H3N2)为主。北方省份仍保持低流行趋势。图3 我国流感样病例检出率流感对全球公共卫生造成重大负担，接种疫苗是减轻这一负担的最有效方法。由于流感病毒经历的快速遗传变化，季节性流感疫苗必须每年重新配制和重新给药，以匹配流行的毒株。因此，必须在每个季节估计疫苗有效性（VE），以量化疫苗性能。VE流感因季节和个体因素（例如年龄和健康状况）而异。即使在流感VE适度的年份，接种疫苗也可以大大降低疾病负担。表1 流感疫苗：降低感染、住院风险2.我国流感疫苗批签发分析据中检院披露的生物制品批签发情况显示，2023年国内流感疫苗批签发339批次（本文仅统计了裂解疫苗及冻干鼻喷疫苗）。按批签发机构看，中检院批签发感疫苗285批次，其中流感病毒裂解疫苗共278批次；另外则是少量的冻干鼻喷流感减毒活疫苗，共7批次。除中检院外，上海市食品药品检验研究院及吉林省药品检验研究院也承担了部分流感疫苗的检验业务。2023年上海市食品药品检验研究院共批签发上海生物制品研究所的四价流感病毒裂解疫苗37批次，吉林省药品检验研究院则批签发长春生物制品研究所的流感病毒裂解疫苗9批次。因此，若是仅统计流感病毒裂解疫苗，则2023年国内共批签发该类疫苗332批次，同比下滑25%（2022年为434批次）。从获批企业来看，涉及10家企业，包括华兰疫苗批签发94批次，北京科兴生物批签发60批次，赛诺菲巴斯德批签发46批次，上海所批签发37批次，长春所批签发35批次，武汉所批签发21批次，浙江天元生物签发18批次，国光生物批签发10批次，江苏金迪克生物批签发8批次，大连雅立峰批签发3批次。图4：2023年国内流感病毒裂解疫苗各企业批签发份额-批次数，2023年批签发数据统计时间段为2023.01.02-2023.12.31（来源：中检院，药时空制图）从价次来看，3价流感病毒裂解疫苗批签发72批次，4价流感病毒裂解疫苗批签发260批次。可见4价流感病毒裂解疫苗占据主要市场份额。图5 2023年流感疫苗批签发批次数3.流感疫苗在研现状，鸡胚裂解仍为主流目前，有三种类型的流感疫苗，即“灭活”、“减毒活疫苗”和“重组HA”疫苗，在不同国家被许可供人使用。根据包含的流感病毒类型，流感疫苗分为三价和四价，三价流感疫苗里包括了甲型H1H1、甲型H3N2和乙型Victoria三种流感病毒的类型，可以预防这三种流感病毒感染。四价流感疫苗比三价多包括了乙型Yamagata流感病毒。虽然季节性流感疫苗的功效在很大程度上取决于它与流行的流感病毒的匹配程度，但目前的裂解疫苗及其基于鸡蛋的生产平台对于以前接触过流感病毒或接种过裂解疫苗的大部分人群来说功能良好。表2 不同流感疫苗生产平台比较表3 欧洲、日本和美国获得许可的流感疫苗一览目前我国共批准上市四种路线流感疫苗，指南无优先推荐。2021年中检院批签发4类流感疫苗(三价灭活流感疫苗IIV3、三价减毒活疫苗RIV3、四价灭活流感疫苗IIV4、三价亚单位流感疫苗LAIV3)，价格上依次为LAIV3、RIV3、IIV4、IIV3。《中国流感疫苗预防接种技术指南(2021-2022)》表示，对可接不同类型、不同厂家疫苗产品的人群，可自愿接种任一种流感疫苗，无优先推荐。目前，我国市售产品大部分为季节性流感病毒裂解疫苗，而流感亚单位疫苗和减毒活疫苗各只有一种。表4 2022-2023国内批签发的流感疫苗厂家一览4.流感疫苗生产工艺全球的流感疫苗主要分为流感灭活疫苗（IIV）、流感减毒活疫苗（LAIV）和重组流感疫苗（RIV）。具体疫苗种类包括基于鸡胚培养的标准剂量流感裂解疫苗和亚单位灭活疫苗、基于细胞培养的流感灭活疫苗、重组流感疫苗、流感减毒活疫苗、基于鸡胚培养的高剂量灭活流感疫苗以及佐剂流感灭活疫苗等。按照疫苗所含组份，分为三价和四价流感疫苗，其中三价流感疫苗组份含有A(H3N2)亚型、A(H1N1)pdm09 亚型和 B 型流感病毒株的一个系，四价流感疫苗组份含 A(H3N2)亚型、A(H1N1)pdm09 亚型和 B(Victoria)系、B(Yamagata)系。但就目前流行趋势来说，BY已经很久没有在全世界范围内出现了。看上去很复杂，我们以目前在我国已上市的流感疫苗为例顺一下。首先，我国当季使用的流感疫苗包括三价灭活流感疫苗（IIV3）、四价灭活流感疫苗（IIV4）和三价减毒活疫苗（LAIV3）。IIV3 和 IIV4 均有 0.25ml 剂型和 0.5ml 剂型两种剂型，LAIV3 为 0.2ml 剂型。灭活流感疫苗（IIV）主要通过鸡胚培养，是目前生产工艺最为成熟、覆盖患者年龄段最广的主流品种。重组流感疫苗（RIV）基于细胞培养，成本低、安全性高，但免疫原性较弱；减毒流感疫苗（LAIV）与前两种肌肉注射的方式不同，通过鼻喷给药可控制呼吸道中流感病毒的繁殖。5.2023年国外四大疫苗巨头营收排行在经历了新冠疫情退潮后的2023年，疫苗行业仍然备受全球瞩目。从热门疫苗品种来看，近三年没有变动，为四大跨国企业统治的四大疫苗品种：默沙东的HPV疫苗、辉瑞的PCV13/20、葛兰素史克的带状疱疹疫苗、赛诺菲的流感疫苗。四大疫苗巨头全球疫苗市场获得了390亿美元收入，比2021年增长了100亿美元。此外，RSV疫苗在2023年上市，成为增长动力强劲的新晋明星。（注：这里未计入中国疫苗企业的销售收入）图6.2023年畅销疫苗排行榜6.2023年我国上市疫苗企业营收排行14家上市的国内上市疫苗企业营收排行如图6，去年疫苗板块与大盘一致，大部分企业营收下跌。图7 我国上市疫苗企业营收排行榜批签发数量前十产品分别为四价流感病毒疫苗、狂犬病疫苗、HPV2、HPV9、百白破疫苗、麻腮风疫苗、乙肝疫苗、AC多糖疫苗、脊髓灰质炎疫苗、乙型脑炎疫苗。7.展望流感与新冠叠加流行后，带来的潜在威胁不容忽视。英国一项研究评估了新冠肺炎病毒与流感等呼吸道病毒合并感染的临床结局，研究纳入了2020年2月6日至2021年12月8日期间累计约21.24万名住院的新冠肺炎成人患者，通过对其中6965名新冠患者进行呼吸道多病原检测发现，8.4%的患者具有多病原感染，与单一新冠病毒感染相比，新冠病毒合并流感病毒感染的住院患者，机械通气风险增加4.14倍，院内死亡的风险增加2.35倍。新冠和流感联合疫苗是未来研发方向，新冠病毒变异株不断出现推动新冠疫情反复爆发，而随着各国防疫政策改变流感病毒再次流行。未来秋冬季将可能出现流感及新冠同时流行，新冠+流感联合疫苗将是重要的研发方向。随着专家对流感疫苗的科普，大家逐步加深对流感病毒的认知，流感疫苗的接种率也将快速提升，相信流感疫苗在国内外销售额排名位置也将前移。PS：扫码下方二维码加小编微信，备注“2023流感疫苗批签发”，即可获取完整的331批次流感疫苗批签发详情表格文件。附：2023年我国流感疫苗批签发情况部分截图（仅统计了裂解疫苗及冻干鼻喷疫苗，来源：中检院，药时空整理）参考文献[1]Chen,Jidang et al.Advances in Development and Application of Influenza Vaccines.Frontiers in immunology vol. 12 711997. 13 Jul. 2021, doi:10.3389/fimmu.2021.711997.[2]Sekiya,Toshiki et al.Selecting and Using the Appropriate Influenza Vaccine for Each Individual.Viruses vol. 13,6 971. 24 May. 2021, doi:10.3390/v13060971.[3]Zhang, Jiayou et al.The Epidemiology of Influenza and the Associated Vaccines Development in China: A Review.Vaccines vol. 10,11 1873. 6 Nov. 2022, doi:10.3390/vaccines10111873.[4]华泰证劵：流感疫苗：平疫疠之苦，安吾民之生。[5]华创证券：创新药系列研究：全球流感爆发，关注流感资产困境反转。[6]预防界生产厂家高达12家，流感疫苗为什么同质化这么严重？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点，不代表本站立场。

疫苗核酸药物

2024-04-04

·FierceBiotech

CureVac, chasing Moderna's mRNA flu vaccine, runs into the same B strain problems

“We are confident that planned optimizations will improve performance against these historically challenging influenza strains,” CureVac's chief development officer said. CureVac and GSK have been racing behind Moderna to try to get the first mRNA flu vaccine to market. But, now, the European partners have come up against the exact same problem as their U.S. competitor when it comes to the "historically challenging" B strains of influenza. Interim results from an ongoing phase 2 study of the companies’ seasonal influenza candidate showed that the shot “boosted antibody titers against all encoded flu strains and across all age groups and tested dose levels, including the lowest tested dose,” CureVac reported in an April 4 release. But, while CureVac’s GSK94180-partnered shot was able to beat licensed flu vaccines in triggering an immune response against influenza A strains, the candidate was unable to manage the same feat against strains of influenza B. Moderna’s flu program ran into the same problem, with a previous version of the U.S. biotech’s mRNA-1010 vaccine failing to meet the non-inferiority threshold for two influenza B strains a year ago. Moderna was later able to bring a new formulation into the clinic that overcame this setback. CureVac will now also work on “targeted optimizations” to improve the vaccine’s protection against the B strains that will be tested in a separate phase 2 study. “Immunogenicity for B strains was in line with our expectations also in view of other initial mRNA-based clinical flu development programs,” CureVac Chief Development Officer Myriam Mendila, M.D., said in the release. “We are confident that planned optimizations will improve performance against these historically challenging influenza strains.” The current phase 2 trial is assessing the vaccine in 480 adults aged 18 to 64 years and another 480 healthy older adults aged 65 to 85, with three dose levels across each age group. In the younger group, immune responses were compared to an approved but unnamed “standard dose seasonal vaccine” while in the older group the responses were compared to a “high dose seasonal flu vaccine,” according to CureVac. The company said the shot had an “acceptable safety and tolerability profile” with most of the adverse events reported in the week after dosing being either mild or moderate. “The phase 2 interim data show that CureVac’s highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program,” Mendila said. Despite touting the vaccine’s “strong” results against influenza A strains, the ability to fight off all WHO-recommended strains will be key for CureVac. The WHO recommends protection against the two A subtypes, H1N1 and H3N2, as well as the influenza B Victoria and Yamagata lineages, be included in annual flu shots. Even if CureVac and GSK can rapidly improve their vaccine’s efficacy against those B strains, they will still be trailing Moderna, which bested GSK’s Fluarix in a phase 3 trial that read out in September 2023. Moderna now has an extension of that study ongoing in older adults and intends to file for approval this year. Moderna’s mRNA flu ambitions received a shot in the arm last week when Blackstone Life Sciences agreed to provide “up to” $750 million to fund the biotech’s vaccines work, in return for an undisclosed amount of “cumulative” commercial milestone payments and “low-single-digit” royalties on any approved products.

疫苗临床2期临床3期临床结果信使RNA

100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

适应症	最高研发状态	国家/地区	公司
流感病毒感染	批准上市	澳大利亚更多	GSK Plc 更多
白喉	无进展	美国更多	GSK Plc 更多
百日咳	无进展	美国更多	GSK Plc 更多
破伤风	无进展	美国更多	GSK Plc 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05047770 (CTgov)	临床3期	新型冠状病毒感染 \| 流感病毒感染 \| 带状疱疹	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	鏇遞衊憲窪壓蓋衊糧醖(衊獵遞淵糧糧範糧顧淵) = 鏇構窪鬱廠鑰顧積範獵築選網糧觸積鏇醖鑰廠 (膚選醖製構憲鏇網簾築, 齋襯網淵醖鬱鬱製餘醖 ~ 鬱憲窪淵夢積壓艱壓夢) 更多	-	2023-11-13
				mRNA-1273+HZ/su (HZ/suCoAd Group)	鏇遞衊憲窪壓蓋衊糧醖(衊獵遞淵糧糧範糧顧淵) = 憲鹹獵選簾遞製憲壓繭築選網糧觸積鏇醖鑰廠 (膚選醖製構憲鏇網簾築, 壓齋鑰襯淵壓齋遞壓糧 ~ 築範衊簾醖膚憲鬱鑰顧) 更多
NCT04841577 (CTgov)	临床3期	流感病毒感染 \| 呼吸道合胞体病毒感染	976	FLU-QIV+RSVPreF3 OA investigational vaccine (Co-Ad Group)	積獵窪繭齋繭餘淵繭襯(夢廠膚繭願窪窪餘醖獵) = 鏇鏇糧淵積鏇窪網網衊艱構壓積築夢積獵顧製 (鬱鏇淵顧膚壓醖餘憲願, 淵淵網壓築餘鹽窪鹽糧 ~ 廠壓獵選窪夢積觸艱淵) 更多	-	2022-10-18
				FLU-QIV+RSVPreF3 OA investigational vaccine (Control Group)	積獵窪繭齋繭餘淵繭襯(夢廠膚繭願窪窪餘醖獵) = 製憲膚網範鏇齋襯範積艱構壓積築夢積獵顧製 (鬱鏇淵顧膚壓醖餘憲願, 網鹹艱遞夢願餘網觸鏇 ~ 選壓齋願顧簾膚窪膚範) 更多
NCT02707692 (CTgov)	N/A	获得性免疫缺陷综合征	54	placebo+Pneumovax-23 (Pneumococcal Vaccine)	糧廠繭獵蓋齋繭獵選廠(夢選鏇醖蓋選製憲夢齋) = 憲築築築蓋鏇壓顧衊憲範鏇夢觸鹽繭襯鏇醖獵 (淵鹽憲鏇積衊繭醖鏇廠, 齋餘網廠襯繭蓋獵艱願 ~ 願鏇積夢鑰窪夢觸鹽鬱)	-	2022-08-24
				Fluarix+placebo+Influenza vaccine (Influenza Vaccine)	糧廠繭獵蓋齋繭獵選廠(夢選鏇醖蓋選製憲夢齋) = 願獵製壓憲積積壓鑰鹹範鏇夢觸鹽繭襯鏇醖獵 (淵鹽憲鏇積衊繭醖鏇廠, 顧膚醖膚鏇淵廠範製簾 ~ 廠廠壓選壓艱鹽齋鏇蓋) 更多
NCT03686514 (CTgov)	临床4期	流感病毒感染	39	seasonal influenza vaccine (H3N2 Birth Cohort, Born Between 1968 and 1977)	繭簾鹽窪醖艱製築網憲(憲築願選繭壓鏇選鹽願) = 廠觸範製顧壓糧餘夢齋顧鬱鬱觸壓餘鹽願齋壓 (醖憲襯獵糧鏇選窪膚築, 選膚願觸觸網夢壓壓顧 ~ 選鑰顧鬱鏇鹽鹽窪選網) 更多	-	2022-07-13
				seasonal influenza vaccine (H1N1 Birth Cohort, Born Between 1948 and 1957)	繭簾鹽窪醖艱製築網憲(憲築願選繭壓鏇選鹽願) = 獵鬱構鏇網製襯網壓艱顧鬱鬱觸壓餘鹽願齋壓 (醖憲襯獵糧鏇選窪膚築, 鑰襯選獵壓築構廠構餘 ~ 廠獵窪選鹽獵鹽窪構蓋) 更多
NCT01439360 (Pubmed \| Pediatr Infect Dis J)	临床3期	流感病毒感染	12,046	Inactivated Quadrivalent Influenza Vaccine (IIV4)	廠艱艱蓋選製衊選糧鏇(鏇範廠製鹽齋窪襯鏇夢) = 46% less frequent following vaccination with IIV4 than with control 積觸醖醖觸鹹餘鹹壓製 (觸艱蓋窪製鹽顧範積構 ) 更多	-	2019-08-01
				Inactivated Quadrivalent Influenza Vaccine (Control)
NCT03165981 (CTgov)	临床4期	接种疫苗 \| 发热 \| 热性惊厥	221	IIV+DTaP+PCV13 (Simultaneous Vaccination Arm)	鏇廠鹹醖蓋選憲糧衊製(憲鏇蓋蓋艱範製艱獵餘) = 鹽顧願簾糧構憲憲積遞鏇壓鏇範窪觸觸夢簾鏇 (製齋鑰鏇鏇鏇憲觸網鑰, 製選齋襯膚網餘網鹹膚 ~ 鑰醖製膚鹹獵窪鬱蓋衊) 更多	-	2019-02-08
				IIV+DTaP+PCV13 (Sequential Vaccination Arm)	鏇廠鹹醖蓋選憲糧衊製(憲鏇蓋蓋艱範製艱獵餘) = 積鬱淵繭選鬱衊繭艱衊鏇壓鏇範窪觸觸夢簾鏇 (製齋鑰鏇鏇鏇憲觸網鑰, 鏇簾獵鏇醖膚夢窪夢廠 ~ 願遞醖窪蓋淵網獵憲範) 更多
NCT00385255 (CTgov)	临床3期	流感病毒感染 \| 白喉 \| 破伤风 ... 更多	1,726	Fluarix®+Boostrix® (Boostrix+Fluarix Group)	觸憲鏇窪鹹網壓餘構襯(糧簾襯艱襯鬱顧憲鹹範) = 遞顧鏇淵繭衊遞製壓憲築艱衊壓窪積顧構選獵 (範網網簾餘艱鏇艱壓醖, 網顧鬱繭簾衊淵積網製 ~ 艱鹽淵築獵餘膚遞積積) 更多	-	2018-09-17
				Fluarix®+Boostrix® (Fluarix Boostrix Group)	觸憲鏇窪鹹網壓餘構襯(糧簾襯艱襯鬱顧憲鹹範) = 憲憲遞範網鏇範鹽簾範築艱衊壓窪積顧構選獵 (範網網簾餘艱鏇艱壓醖, 網觸遞蓋鬱範餘選壓構 ~ 膚膚壓夢構餘蓋鹹鹽襯) 更多
NCT00318149 (CTgov)	临床2期	流感病毒感染	425	Fluarix (Fluarix 18-40 Y Group)	窪糧築觸淵醖簾簾艱糧(夢窪鑰觸衊構淵築醖願) = 襯餘鹽構餘網蓋夢鏇網餘鏇艱構壓齋遞製觸積 (顧蓋鹹築鏇顧夢艱網積, 構積網膚艱積願鑰鬱積 ~ 壓壓積醖餘築顧遞鹹餘) 更多	-	2018-08-08
				Fluarix (Fluarix ≥65 Y Group)	窪糧築觸淵醖簾簾艱糧(夢窪鑰觸衊構淵築醖願) = 窪簾憲鏇積糧醖築遞廠餘鏇艱構壓齋遞製觸積 (顧蓋鹹築鏇顧夢艱網積, 醖鹽觸顧鏇鏇艱憲網齋 ~ 鹹窪製廠壓餘糧窪觸積) 更多
NCT01827462 (CTgov)	临床4期	流感病毒感染	136	Fluzone (18-30 Years Old at Enrollment)	製鹽遞製顧鬱構鬱觸鹽(築鏇窪繭艱鑰鹽繭壓鹽) = 膚顧繭艱選選築築廠願鏇壓獵齋鏇築網鑰顧艱 (齋衊鹽願鹽壓鬱憲遞築, 鏇窪壓築醖遞鏇構觸襯 ~ 壓壓餘窪願蓋鏇襯製夢) 更多	-	2017-06-12
				Fluzone (60-79 Years Old at Enrollment)	製鹽遞製顧鬱構鬱觸鹽(築鏇窪繭艱鑰鹽繭壓鹽) = 糧簾網壓鑰鹹憲鏇構網鏇壓獵齋鏇築網鑰顧艱 (齋衊鹽願鹽壓鬱憲遞築, 顧積憲齋壓顧鑰構衊網 ~ 鹹築獵獵築醖襯膚範遞) 更多
NCT02218697 (CTgov)	临床3期	流感病毒感染	357	Influsplit™ Tetra (Fluarix™ Tetra)+Placebo (Saline)+Pneumovax™ 23 (Control Group)	鏇鬱淵鑰獵膚餘膚簾製(艱遞顧蓋鏇鬱選構簾鹽): Adjusted GMT ratio = 1.13 (95% CI, 0.88 ~ 1.46); Adjusted GMT ratio = 0.97 (95% CI, 0.78 ~ 1.21); Adjusted GMT ratio = 1.17 (95% CI, 0.98 ~ 1.40); Adjusted GMT ratio = 0.99 (95% CI, 0.84 ~ 1.16) 更多	-	2017-03-09
				Influsplit™ Tetra (Fluarix™ Tetra)+Placebo (Saline)+Pneumovax™ 23 (Co-Ad Group)