甲型流感病毒疫苗H5N1(Novartis Pharma AG)(Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH))

概要

基本信息

药物类型

预防性疫苗

别名

Influenza A virus vaccine H5N1(Novartis Pharma AG)、influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)、prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

+ [1]

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

H5N1流感禽流感

非在研适应症-

原研机构

Seqirus GmbH

在研机构

Seqirus Ltd.

非在研机构

Novartis Vaccines & Diagnostics Srl

最高研发阶段批准上市

首次获批日期

欧盟 (2010-11-28),

H5N1流感禽流感

最高研发阶段(中国)-

特殊审评-

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关联

7

项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的临床试验

NCT00798343 / Completed临床1期IIT

Evaluation of Heterosubtypic Immune Responses in Older People Before and After Seasonal and Pandemic Influenza Vaccination

Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines induce relatively strain-specific and short-lived antibody responses, annual immunisation with regularly updated vaccine is recommended for seasonal influenza, but would not be expected to protect against a pandemic event. In clinical trials among young adults, at least two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate antibody responses. However, studies including older subjects have unexpectedly found that some people aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and H9 respectively. These subjects mount a robust antibody response to single dose H5 or H9 pandemic vaccine, suggesting that they are effectively primed to at least some strains of avian influenza.
This exploratory proposal focuses on those elderly subjects whose immune systems already exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the immune response to seasonal and pandemic vaccination. We will examine neutralising antibody responses to a range of human and non-human influenza viruses before and after seasonal and pandemic vaccination and evaluate cellular B and T cell immune responses before and after pandemic H5 vaccination

开始日期2009-01-01

申办/合作机构

University Hospitals of Leicester

[+3]

NCT00814385 / Completed临床1/2期IIT

A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine

This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.

开始日期2008-11-01

申办/合作机构

University Hospitals of Leicester

[+4]

JPRN-JMA-IIA00017 / Completed临床4期IIT

Phase IV, Open-label Study to Assess the Durability and Cross-immunity of H5N1 influenza vaccine in Healthy Adult Japanese Volunteers

开始日期2008-08-01

申办/合作机构-

100 项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的临床结果

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100 项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的转化医学

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100 项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的专利（医药）

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2

项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的文献（医药）

2013-01-01·Expert Opinion on Biological Therapy3区 · 医学

Aflunov®: a vaccine tailored for pre-pandemic and pandemic approaches against influenza

3区 · 医学

Review

作者: Del Giudice, Giuseppe ; Della Cioppa, Giovanni ; Rappuoli, Rino ; Fragapane, Elena

INTRODUCTIONAflunov is an egg-derived, subunit vaccine from Novartis Vaccines and Diagnostics containing 7.5 μg of hemagglutinin (HA) from the avian A/H5N1 virus and the oil-in-water adjuvant MF59.AREAS COVEREDAflunov behaves as a pre-pandemic vaccine. It has a good safety profile at all ages. At all ages, it induces high and persisting antibody titers and activation of HA-specific Th0/Th1 CD4(+) T cells, the levels of which correlate with the neutralizing antibody titers after a booster dose 6 months later. Aflunov triggers strong immunological memory, which persists for at least 6 - 8 years and can be rapidly boosted with a heterovariant vaccine strain, inducing very high neutralizing antibody titers within one week. These antibodies broadly and strongly cross-react with drifted H5N1 virus strains from various clades. Finally, the MF59 changes the pattern of HA recognition by antibodies that react with the HA1 more than with the HA2 region.EXPERT OPINIONThe available data show that Aflunov is a pre-pandemic vaccine suitable not only for stockpiling in case of a pandemic, but also before a pandemic is declared, with the ultimate objective of preventing the onset of an influenza pandemic.

2012-02-01·Expert Review of Vaccines2区 · 医学

Aflunov^®: a prepandemic influenza vaccine

2区 · 医学

Review

作者: Panatto, Donatella ; Lai, Piero Luigi ; Gasparini, Roberto ; Amicizia, Daniela

Influenza viruses are adept in human populations. Indeed, they have the capacity to evade the immune system through mechanisms of mutations (antigenic drift) and major variations in surface protein expression (antigenic shift). When a major change occurs, the risk of a human pandemic arises. Three influenza pandemics occurred during the 20th century, the most serious being the Spanish influenza. The last pandemic of the past century occurred in 1968, and the responsible virus infected an estimated 1-3 million people throughout the world. The first pandemic of the present century occurred in 2009 and was sustained by a H1N1 strain (A/California/07/09). In 1997, a novel avian influenza virus, H5N1, first infected humans in China. Since its emergence, the H5N1 virus has spread from Asia to Europe and Africa, resulting in the infection of millions of poultry and wild birds. So far, 522 human cases and 322 deaths have been reported by the WHO. Many studies have therefore been performed to obtain efficacious and safe H5N1 vaccines. One of these is Aflunov(®). Aflunov is a prepandemic monovalent A/H5N1 influenza vaccine adjuvanted with MF59 produced by Novartis Vaccines and Diagnostics. In nonclinical studies conducted in rabbits, Aflunov proved to be well-tolerated, did not cause maternal or embryo-fetal toxicity, was not teratogenic, and had no effects on postnatal development. In clinical studies, Aflunov proved safe and well-tolerated in infants, children, adolescents, adults and the elderly. In the same subjects, the vaccine elicited robust immunogenicity against both homologous (A/Vietnam/1194/2004 clade 1) and heterologous viral strains (for instance, A/Indonesia/05/2005 or A/Turkey/15/2006) and induced immunologic memory. Thus, in 2010, the CHMP issued a positive opinion on Aflunov and in January 2011 Aflunov was given marketing authorization. This vaccine could be very useful in the event of adaptation of the H5N1 virus to humans, which could cause a new pandemic.

100 项与甲型流感病毒疫苗H5N1(Novartis Pharma AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲型流感病毒疫苗H5N1(Novartis Pharma AG)	J07BB02	-

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
H5N1流感	欧盟	Seqirus Ltd.	2010-11-28
H5N1流感	列支敦士登	Seqirus Ltd.	2010-11-28
H5N1流感	冰岛	Seqirus Ltd.	2010-11-28
H5N1流感	挪威	Seqirus Ltd.	2010-11-28
禽流感	冰岛	Seqirus Ltd.	2010-11-28
禽流感	列支敦士登	Seqirus Ltd.	2010-11-28
禽流感	挪威	Seqirus Ltd.	2010-11-28
禽流感	欧盟	Seqirus Ltd.	2010-11-28

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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


NCT00481065 (CTgov)	临床2期	禽流感 \| 流感病毒感染	405	eTIV_a+MF59-eH5N1 (Concomitant Alone)	築遞獵艱鏇築壓蓋繭構(醖構選壓壓膚範鑰積顧) = 遞鹽鏇膚簾壓鑰構鑰獵艱膚鏇膚醖製積網餘選 (齋鹹窪襯膚壓範淵壓繭, 鏇選鬱醖願鏇窪憲醖衊 ~ 襯鹹觸觸襯願繭鹽蓋餘) 更多	-	2013-02-28
				eTIV_a+MF59-eH5N1 (Mixed)	築遞獵艱鏇築壓蓋繭構(醖構選壓壓膚範鑰積顧) = 鑰築醖繭簾淵願觸製遞艱膚鏇膚醖製積網餘選 (齋鹹窪襯膚壓範淵壓繭, 築簾積簾獵鹽範齋廠餘 ~ 網夢觸夢鏇膚網鑰顧鹽) 更多