Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.)(Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

Inactivated H1N1 vaccine (unadjuvanted)、Influenza A/H1N1 2009 vaccine、Swine flu vaccine

+ [3]

靶点-

作用方式

刺激剂

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

甲型流感病毒感染

非在研适应症-

原研机构

CSL Ltd.

在研机构

CSL Ltd.

非在研机构

Seqirus GmbH

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2009-09-15),

甲型流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的临床试验

NCT00940108

/ Completed临床2期

A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.

开始日期2009-08-01

申办/合作机构

Seqirus GmbH

NCT00958126

/ Completed临床2期

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

开始日期2009-08-01

申办/合作机构

Seqirus GmbH

NCT00958243

/ Completed临床2期

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

开始日期2009-08-01

申办/合作机构

Seqirus GmbH

100 项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的临床结果

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100 项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的转化医学

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100 项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的专利（医药）

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131

项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的文献（医药）

2024-01-01·Vaccine

An experimental universal swine influenza a virus (IAV) vaccine candidate based on the M2 ectodomain (M2e) peptide does not provide protection against H1N1 IAV challenge in pigs

Article

作者: Lee, Hui-Min ; Magstadt, Drew R ; Gauger, Phillip C ; Digard, Paul ; Opriessnig, Tanja ; Rawal, Gaurav ; Halbur, Patrick G ; Filippsen Favaro, Patricia

Swine flu is a common disease problem in North American pig populations and swine influenza A viruses (IAV) are extremely diverse and the lack of cross protection between heterologous strains is impacting vaccine efficacy in the field. The objective of this study was to design and test a novel swine flu vaccine targeting the M2 ectodomain (M2e) of IAV, a highly conserved region within the IAV proteome. In brief, an M2e peptide was designed to match the predominant swine IAV M2 sequence based on global analysis of sequences from pigs and humans. The resulting sequence was used to synthesize the M2e peptide coupled to a carrier protein. The final vaccine concentration was 200 µg per dose, and a commercial, microemulsion-based aqueous adjuvant was added. Nine 3-week-old IAV negative piglets were randomly assigned to three groups and rooms including non-vaccinated pigs (NEG-CONTROLs) and vaccinated pigs using the intramuscular (M2e-IM) or the intranasal route (M2e-IN). Vaccinations were done at weaning and again at 2 weeks later. An in-house enzyme-linked immunosorbent assay (ELISA) was developed and validated to study the M2e IgG antibody response and demonstrated M2e-IM pigs had a higher systemic antibody response compared to M2e-IN pigs. Subsequently, an IAV challenge study was conducted. The results indicated that M2e-IM vaccinated pigs were not protected from H1N1 (US pandemic clade, global clade 1A.3.3.2) challenge despite having a strong humoral anti-M2e immune response. In conclusion, while the experimental IAV vaccine was able to induce anti-M2e antibodies, when challenged with H1N1, the vaccinated pigs were not protected, perhaps indicating that reactivity to the M2e antigen alone is not sufficient to reduce clinical signs, lesions or shedding associated with experimental IAV challenge.

2019-12-01·Journal of Translational Internal Medicine2区 · 医学

Influenza vaccination and Guillain–Barré syndrome: Reality or fear

2区 · 医学

Review

作者: Javanian, Mostafa ; Karkhah, Ahmad ; Mohseni Afshar, Zeinab ; Koppolu, Veerendra ; Masrour-Roudsari, Jila ; Mohammadnia-Afrouzi, Mousa ; Babazadeh, Arefeh ; Ebrahimpour, Soheil ; Sabbagh, Parisa ; Vasigala, Veneela KrishnaRekha

AbstractGuillain–Barré syndrome (GBS) is an inflammatory disorder and an acute immune-mediated demyelinating neuropathy that causes reduced signal transmissions, progressive muscle weakness, and paralysis. The etiology of the syndrome still remains controversial and uncertain. GBS can be initiated and triggered by respiratory tract infections such as influenza, and intestinal infections such as Campylobacter jejuni. In addition, there is considerable evidence suggesting links between influenza vaccination and GBS. As reported previously, the incidence of GBS in individuals receiving swine flu vaccine was about one to two cases per million. Despite the influenza vaccine efficacy, its association with an immune-mediated demyelinating process can be challenging as millions of people get vaccinated every year. In this review we will discuss the association between influenza infection and vaccination with GBS by focusing on the possible immunopathological mechanisms.

2017-01-01·Disease Markers4区 · 医学

Impact of Vaccination on Distribution of T Cell Subsets in Antiretroviral-Treated HIV-Infected Children

4区 · 医学

ArticleOA

作者: Khowawisetsut, Ladawan ; Ammaranond, Palanee ; Tantithavorn, Varangkana ; Onlamoon, Nattawat ; Thitilertdecha, Premrutai ; Poungpairoj, Poonsin

Antiretroviral therapy (ART) is generally prescribed to patients with human immunodeficiency virus (HIV) infection with vaccination introduced to prevent disease complications. However, little is known about the influence of immunization on T cell subsets’ distribution during the course of infection. This study aims to identify the impact of viral replication and immunization on naïve, effector, effector memory, and central memory T cell subpopulations in ART-treated HIV-infected children. Fifty patients were recruited and injected intramuscularly with influenza A (H1N1) 2009 vaccine on the day of enrollment (day 0) and day 28. Blood samples were collected for pre- and postvaccination on days 0 and 56 for analyzing T cell phenotypes by flow cytometry. Phenotypes of all T cell subsets remained the same after vaccination, except for a reduction in effector CD8+ T cells. Moreover, T cell subsets from patients with controllable viral load showed similar patterns to those with virological failure. Absolute CD4 count was also found to have a positive relationship with naïve CD4+ and CD8+ T cells. In conclusion, vaccination and viral replication have a little effect on the distribution of T cell subpopulations. The CD4 count can be used for prediction of naïve T cell level in HIV-infected patients responding to ART.

100 项与 Influenza A (H1N1) 2009 monovalent vaccine(CSL Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
甲型流感病毒感染	美国	CSL Ltd.	2009-09-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	临床前	美国	Seqirus GmbH	2009-08-01
甲型流感病毒感染	临床前	澳大利亚	Seqirus GmbH	2009-07-01

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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


NCT00938639 (CTgov)	临床2期	甲型流感病毒感染	240	CSL425 (CSL425 (15 mcg))	製鬱窪遞獵鹹齋淵遞壓(積獵艱網廠積構膚網夢) = 網遞顧齋鏇夢簾築膚觸壓膚鹹築醖憲蓋構簾簾 (顧製壓艱壓積願壓艱鹹, 膚範窪窪遞夢蓋淵構憲 ~ 積窪鬱鏇齋蓋鏇餘選願) 更多	-	2013-11-21
				CSL425 (CSL425 (30 mcg))	製鬱窪遞獵鹹齋淵遞壓(積獵艱網廠積構膚網夢) = 憲鑰糧鹽壓蓋蓋觸淵簾壓膚鹹築醖憲蓋構簾簾 (顧製壓艱壓積願壓艱鹹, 壓遞蓋醖餘膚遞製製獵 ~ 築簾醖齋窪糧簾衊築鬱) 更多
NCT00940108 (CTgov)	临床2期	甲型流感病毒感染	370	CSL425 (CSL425 (15 mcg) Cohort A)	鏇廠廠餘觸膚繭顧繭構(壓鹽鏇鑰鹽構齋齋廠選) = 醖範觸淵遞選築糧願觸窪糧糧鏇繭餘艱鹽築選 (遞遞壓窪餘製鹽鬱衊醖, 壓繭鑰範壓憲鬱鬱獵鹽 ~ 願襯夢鬱顧廠鬱鑰願憲) 更多	-	2013-11-20
				CSL425 (CSL425 (30 mcg) Cohort A)	鏇廠廠餘觸膚繭顧繭構(壓鹽鏇鑰鹽構齋齋廠選) = 製壓鹽醖膚願壓窪窪糧窪糧糧鏇繭餘艱鹽築選 (遞遞壓窪餘製鹽鬱衊醖, 遞鹹鏇夢醖鬱艱繭膚窪 ~ 範憲廠選鑰積選選簾鹽) 更多