甲型流感病毒H5N1疫苗(CSL Ltd.)(Influenza A virus H5N1 vaccine(CSL Ltd.)) - 在研适应症：流感病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

Avian influenza (bird flu) virus vaccine - CSL、CSL444 (Pandemic ISCOMATRIX Flu)、H5N1 aluminium pandemic influenza vaccine (CSL Ltd)

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靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染

非在研适应症-

原研机构

CSL Ltd.

在研机构

Seqirus UK LimitedSeqirus Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2009-10-18),

流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

4

项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的临床试验

NCT03497845 / Completed临床2期IIT

Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.
The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.

开始日期2018-03-15

申办/合作机构

Biomedical Advanced Research and Development Authority (BARDA)

NCT00478816 / Completed临床2期

A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-adjuvanted or Non-adjuvanted H5N3 Influenza Vaccines

Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects

开始日期2007-05-01

申办/合作机构-

NCT00376402 / Completed临床2期

Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.

开始日期2006-10-01

申办/合作机构

Seqirus GmbH

100 项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的临床结果

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100 项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的转化医学

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100 项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的专利（医药）

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23

项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的文献（医药）

2021-10-01·Nanomedicine: Nanotechnology, Biology and Medicine2区 · 医学

RNA-dependent assembly of chimeric antigen nanoparticles as an efficient H5N1 pre-pandemic vaccine platform

2区 · 医学

Article

作者: Cheong, Yucheol ; Jang, Yo Han ; Chae, Wonil ; Kim, Young-Seok ; Lim, Jongkwan ; Seo, Sang-Uk ; Seong, Baik L ; Hwang, Beom Jeung ; Roh, Young Hoon ; Lee, Jinhee

Highly pathogenic avian influenza viruses (HPAIVs) pose a significant threat to human health, with high mortality rates, and require effective vaccines. We showed that, harnessed with novel RNA-mediated chaperone function, hemagglutinin (HA) of H5N1 HPAIV could be displayed as an immunologically relevant conformation on self-assembled chimeric nanoparticles (cNP). A tri-partite monomeric antigen was designed including: i) an RNA-interaction domain (RID) as a docking tag for RNA to enable chaperna function (chaperna: chaperone + RNA), ii) globular head domain (gd) of HA as a target antigen, and iii) ferritin as a scaffold for 24 mer-assembly. The immunization of mice with the nanoparticles (~46 nm) induced a 25-30 fold higher neutralizing capacity of the antibody and provided cross-protection from homologous and heterologous lethal challenges. This study suggests that cNP assembly is conducive to eliciting antibodies against the conserved region in HA, providing potent and broad protective efficacy.

2021-07-01·Cell1区 · 生物学

The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination

1区 · 生物学

Article

作者: Maecker, Holden T ; Chang, Sarah E ; Ashuach, Tal ; Rouphael, Nadine ; Utz, Paul J ; van der Most, Robbert ; Cheung, Peggie ; Foecke, Mariko Hinton ; Davis, Mark ; Pulendran, Bali ; Li, Chunfeng ; De Jong, Sanne E ; Wimmers, Florian ; Bosinger, Steven E ; Gupta, Shakti ; Cortese, Mario ; Kuo, Alex ; Subramaniam, Shankar ; Dvorak, Mai ; Yosef, Nir ; Hagan, Thomas ; Donato, Michele ; Khatri, Purvesh

Emerging evidence indicates a fundamental role for the epigenome in immunity. Here, we mapped the epigenomic and transcriptional landscape of immunity to influenza vaccination in humans at the single-cell level. Vaccination against seasonal influenza induced persistently diminished H3K27ac in monocytes and myeloid dendritic cells (mDCs), which was associated with impaired cytokine responses to Toll-like receptor stimulation. Single-cell ATAC-seq analysis revealed an epigenomically distinct subcluster of monocytes with reduced chromatin accessibility at AP-1-targeted loci after vaccination. Similar effects were observed in response to vaccination with the AS03-adjuvanted H5N1 pandemic influenza vaccine. However, this vaccine also stimulated persistently increased chromatin accessibility at interferon response factor (IRF) loci in monocytes and mDCs. This was associated with elevated expression of antiviral genes and heightened resistance to the unrelated Zika and Dengue viruses. These results demonstrate that vaccination stimulates persistent epigenomic remodeling of the innate immune system and reveal AS03's potential as an epigenetic adjuvant.

2019-04-01·Archives of Virology4区 · 医学

Analysis of the efficacy of an adjuvant-based inactivated pandemic H5N1 influenza virus vaccine

4区 · 医学

Article

作者: Makbuz, Amanzhol ; Kassenov, Markhabat ; Sansyzbay, Abylay ; Renukaradhya, Gourapura J ; Volgin, Yevgeniy ; Khairullin, Berik ; Rametov, Nurkuisa ; Sagymbay, Altynay ; Tabynov, Kaissar ; Nurpeisova, Ainur

This paper describes a preclinical study analyzing the immunogenicity and protective efficacy of Kazfluvac^®, an adjuvant-based inactivated pandemic influenza A/H5N1 virus vaccine. In this study, laboratory animals (ferrets and mice) were vaccinated by the intramuscular or intraperitoneal route at an interval of 14 days with two doses of the vaccine containing different concentrations of influenza virus hemagglutinin (HA) protein. HA protein without adjuvant (aluminum hydroxide and Merthiolate) was used as a control. As a negative control, we utilized PBS. We assessed the protective efficacy of the candidate vaccine by analyzing the response to challenge with the influenza virus strain A/chicken/Astana/6/05 (H5N1). Our experimental results revealed substantially reduced clinical disease and an increased antibody response, as determined by hemagglutination-inhibition (HAI) test and microneutralization assay (MNA). This study showed that the candidate vaccine is safe and elicits an antigen-dose-dependent serum antibody response. In summary, we determined the optimum antigen dose in a Kazfluvac^® adjuvant formulation required for induction of heightened immunogenicity and protective efficacy to mitigate H5N1 disease in experimental animals, suggesting its readiness for clinical studies in humans.

100 项与甲型流感病毒H5N1疫苗(CSL Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲型流感病毒H5N1疫苗(CSL Ltd.)	J07BB01	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
流感病毒感染	挪威	Seqirus Ltd.	2009-10-18
流感病毒感染	列支敦士登	Seqirus Ltd.	2009-10-18
流感病毒感染	欧盟	Seqirus Ltd.	2009-10-18
流感病毒感染	冰岛	Seqirus Ltd.	2009-10-18