Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)(Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

Adjupanrix、Influenza A virus vaccine H5N1、pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

+ [6]

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

GSK Plc

在研机构

GlaxoSmithKline Biologicals SA

非在研机构

GSK Plc

最高研发阶段批准上市

首次获批日期

欧盟 (2009-10-10),

流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

10

项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的临床试验

NCT01910519

/ Completed临床2期IIT

Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)

This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

开始日期2013-07-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT01379937

/ Completed临床3期

Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

开始日期2011-07-28

申办/合作机构

GSK Plc

NCT01323946

/ Completed临床2期

Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

开始日期2011-04-18

申办/合作机构

GSK Plc

100 项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的专利（医药）

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7

项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的文献（医药）

2019-06-01·Vaccine3区 · 医学

Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1

3区 · 医学

Article

作者: Seipelt, Joachim ; Groiss, Franz ; Muster, Thomas ; Wolschek, Markus ; Kiselev, Oleg ; Nicolodi, Christina

BACKGROUND:

Traditional inactivated influenza vaccines are the type of vaccines that were most frequently developed for immunization against the highly pathogenic avian H5N1 influenza virus. However, clinical trials with inactivated influenza vaccines for H5N1 indicated that high doses and at least two immunizations are required for an effective immune response (Nicholson et al., 2001; Treanor, Campbell et al., 2006; Treanor, Schiff et al., 2006; Ehrlich et al., 2008). We investigated the safety and immunogenicity of a live attenuated H5N1 vaccine (delNS1-H5N1) lacking the interferon antagonist nonstructural protein 1 (NS1).

METHODS:

We conducted a double-blind, placebo-controlled, phase 1 study in healthy adult participants who were randomly assigned at a 2:1 ratio to receive two immunizations of delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID₅₀)/subject or 7.5 log10 TCID₅₀/subject, or placebo.

RESULTS:

Intranasal vaccination with the live attenuated delNS1-H5N1 vaccine was safe and well tolerated. The most common adverse events identified were symptoms associated with mild influenza infections, such as increased body temperature (>37.0 °C), pharyngeal erythema, rhinitis and throat irritation, and were reported within 7 days after the first immunization. delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID₅₀/subject. Seroconversion occurred in 75% of study participants after only one immunization with 7.5 log10 TCID₅₀/subject. Vaccine-specific local IgA responses were observed in 41.7% of individuals that showed serum antibody responses after 2nd immunization.

CONCLUSIONS:

We show that vaccination with a live attenuated H5N1 influenza vaccine lacking NS1 is safe and induces significant levels of vaccine-specific antibodies even after one immunization. The safety and immunogenicity data indicate that delNS1-H5N1 has the potential to fulfil the unmet need for an effective influenza vaccine in pandemic situations. (ClinicalTrials.gov identifier NCT03745274).

2016-05-01·Virology3区 · 医学

A cationic liposome–DNA complexes adjuvant (JVRS-100) enhances the immunogenicity and cross-protective efficacy of pre-pandemic influenza A (H5N1) vaccine in ferrets

3区 · 医学

Article

作者: Fairman, Jeffery ; Liu, Feng ; Tumpey, Terrence M ; Sun, Xiangjie ; Lu, Xiuhua ; Lewis, David B ; Levine, Min ; Katz, Jacqueline M

Influenza A (H5N1) viruses continue to pose a public health threat. As inactivated H5N1 vaccines are poorly immunogenic, adjuvants are needed to improve the immunogenicity of H5N1 vaccine in humans. Here, we investigated the immunogenicity and cross-protective efficacy in ferrets of a clade 2.2-derived vaccine with addition of JVRS-100, an adjuvant consisting of cationic liposome-DNA complexes (CLDC). After the first vaccination, significantly higher levels of hemagglutination-inhibition (HAI) and neutralizing antibody titers were detected in ferrets immunized with adjuvanted vaccine compared to unadjuvanted vaccine. Following a second dose of adjuvanted vaccine, HAI antibody titers of ≥ 40 were detected against viruses from multiple H5N1 clades. HAI antibodies against newly isolated H5N2 and H5N8 viruses were also augmented by JVRS-100. Ferrets were challenged with a heterologous H5N1 virus. All ferrets that received two doses of adjuvanted vaccine exhibited mild illness, significantly reduced nasal wash virus titers and protection from lethal challenge. In contrast, ferrets that received unadjuvanted vaccine showed greater weight loss, high viral titers and 3 of 6 animals succumbed to the lethal challenge. Our results indicate that the addition of JVRS-100 to H5N1 vaccine enhanced immunogenicity and cross-protection against lethal H5N1 virus disease in ferrets. JVRS-100 warrants further investigation as a potential adjuvant for influenza vaccines.

2015-03-01·Influenza and other respiratory viruses3区 · 医学

Phase II, randomized, open, controlled study of AS03‐adjuvanted H5N1 pre‐pandemic influenza vaccine in children aged 3 to 9 years: follow‐up of safety and immunogenicity persistence at 24 months post‐vaccination

3区 · 医学

ArticleOA

作者: Gillard, Paul ; Ubeda, Isabel ; Teko, Maurice ; Planelles‐Catarino, Maria Victoria ; Moris, Philippe ; Díez‐Domingo, Javier ; Garcia‐Corbeira, Pilar ; Garcés‐Sánchez, María ; Vanden Abeele, Carline ; Marès, Josep ; Baldó, José‐María ; Jubert–Rosich, Angels

Background:

An AS03‐adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years.

Methods:

In this follow‐up of the Phase II study, we report immunogenicity persistence and safety at 24 months post‐vaccination in children aged 3–9 years. The randomized, open‐label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune‐mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination‐inhibition assay 12 and 24 months after vaccination; cross‐reactivity and cell‐mediated responses were also assessed. (NCT00502593).

Results:

The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine‐related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell‐mediated immunity was strong, and CD4+ T cells with a TH1 profile were observed.

Conclusions:

Two doses of an AS03‐adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell‐mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination.

1

项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的新闻（医药）

2022-07-29

·Pm Live

GSK to supply 85 million doses of pandemic influenza vaccine to EU

GSK has signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of its pandemic influenza vaccine, Adjupanrix, to support pandemic preparedness in Europe. The contract is one of the first signed by HERA since it was launched by the EC in September 2021 with a mission to ‘prevent, detect and rapidly respond to health emergencies’. Roger Conner, president of Vaccines and Global Health at GSK, said: “I’m delighted that HERA has chosen GSK as a key partner in pandemic flu preparedness… We have all seen the devastating human, economic and social consequences of a pandemic and the important part that vaccines are playing in helping us return to normal life. Through this agreement for 85 million doses, we can help the EU and European countries, as well as other countries and regions, be better prepared for future pandemics.” Adjupanrix is a vaccine for use in adults to protect against pandemic influenza and, according to the European Medicines Agency (EMA), should only be used once an influenza pandemic has been officially declared by the World Health Organization (WHO) or the EU. Adjupanrix is a ‘mock-up’ vaccine, a type of vaccine that can be developed to help with the management of a future pandemic. Before an influenza pandemic begins, the strain of flu virus involved is unknown, so the correct vaccine cannot be prepared in advance. Instead, a vaccine can be prepared that contains a strain of flu virus to which very few people are immune. This vaccine can then be tested in advance to see how people react to it, allowing for the prediction of how people will react when the flu strain causing the pandemic is included. GSK has signed a number of contracts this year under which the company could provide at least 200 million doses of the pandemic influenza vaccine to governments around the world. In February, the company extended its pandemic influenza vaccine stockpile contract with the US government. This was followed by a renewed agreement in June for supply of pandemic influenza vaccines to the World Health Organization (WHO) and a contract with the government of Canada in July for both seasonal and pandemic influenza vaccines.

疫苗

100 项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)	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
流感病毒感染	欧盟	GlaxoSmithKline Biologicals SA	2009-10-10
流感病毒感染	冰岛	GlaxoSmithKline Biologicals SA	2009-10-10
流感病毒感染	列支敦士登	GlaxoSmithKline Biologicals SA	2009-10-10
流感病毒感染	挪威	GlaxoSmithKline Biologicals SA	2009-10-10

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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


NCT01910519 (CTgov)	临床2期	H5N1流感	50	AS03 (Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant)	築窪蓋膚選鏇獵網餘窪(積觸簾衊蓋淵鹽壓餘簾) = 遞選衊窪餘鏇醖餘鑰鑰構獵築齋積壓窪餘淵夢 (鹹網鏇夢鹽鹽鹹鏇壓醖, 網襯夢願襯襯襯憲網淵 ~ 網鏇窪鬱廠鏇範夢蓋糧) 更多	-	2019-02-12
				AS03 (Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv)	築窪蓋膚選鏇獵網餘窪(積觸簾衊蓋淵鹽壓餘簾) = 網淵廠窪衊鑰獵遞獵製構獵築齋積壓窪餘淵夢 (鹹網鏇夢鹽鹽鹹鏇壓醖, 窪遞餘夢鏇鏇鑰範窪製 ~ 壓壓築製築淵鹹繭遞顧) 更多
NCT01323946 (CTgov)	临床2期	流感病毒感染	113	GSK Biologicals' investigational vaccine GSK1562902A (GSK1562902A 6 to 12 M Group)	積醖觸衊窪餘衊艱構餘(遞糧積構艱遞選鹽觸觸) = 鹽鑰壓襯窪繭淵築鹹蓋簾範鏇顧選淵鏇蓋淵鏇 (壓膚繭製構構構衊網壓, 憲築艱願餘製鏇範簾膚 ~ 鏇遞觸壓艱繭獵衊鑰艱) 更多	-	2019-02-04
				GSK Biologicals' investigational vaccine GSK1562902A (GSK1562902A 12 to 24 M Group)	積醖觸衊窪餘衊艱構餘(遞糧積構艱遞選鹽觸觸) = 鬱遞遞壓遞淵鬱鹽壓遞簾範鏇顧選淵鏇蓋淵鏇 (壓膚繭製構構構衊網壓, 夢鏇範夢淵網鑰選構鹹 ~ 衊獵繭鏇餘簾夢網顧願) 更多
NCT00506350 (CTgov)	临床2期	流感病毒感染	350	Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F1 Primed Group)	淵憲鏇壓鹹網願餘構鏇(淵齋窪衊積網遞淵構壓) = 範鹽鹹壓糧網獵襯窪鬱壓壓積窪餘衊餘獵廠襯 (構壓蓋範餘願繭選衊顧, 醖鬱鬱鏇淵廠艱糧艱遞 ~ 蓋鏇憲鹽製憲構鹽顧壓) 更多	-	2017-10-04
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	淵憲鏇壓鹹網願餘構鏇(淵齋窪衊積網遞淵構壓) = 廠憲繭鑰艱遞醖餘廠鹽壓壓積窪餘衊餘獵廠襯 (構壓蓋範餘願繭選衊顧, 觸鹹構繭簾窪積鑰膚鬱 ~ 廠糧鏇製鹽淵積遞壓鑰) 更多
NCT01379937 (115115, CTgov)	临床3期	流感病毒感染	520	Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group)	積網選鑰願糧衊遞鏇鏇(廠構範選選憲範簾觸願) = 壓憲鹹鏇餘觸鬱壓網窪選獵獵襯顧窪鏇衊鬱願 (鏇鏇遞艱廠餘鹽構構襯, 膚鏇鏇齋觸選餘網構選 ~ 壓襯襯鑰範襯壓範鏇鏇) 更多	-	2014-03-26
				Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 2 - Havrix / Havrix Jr Group)	積網選鑰願糧衊遞鏇鏇(廠構範選選憲範簾觸願) = 壓鬱餘顧構構憲衊繭製選獵獵襯顧窪鏇衊鬱願 (鏇鏇遞艱廠餘鹽構構襯, 積醖願夢顧觸鹽鹹築築 ~ 糧醖餘築遞獵夢構繭繭) 更多
NCT00695669 (CTgov)	临床2期	流感病毒感染	312	Influenza A (H5N1) Virus Monovalent Vaccine (Influenza A (H5N1) 1 Group)	餘繭襯鹹餘糧網築繭夢(衊積構齋膚觸選鑰遞網) = 網衊鬱築選選壓製鑰鏇餘齋選窪壓淵遞鹽選鹹 (衊齋獵製壓鏇顧遞網窪, 齋餘衊顧襯網憲壓壓鏇 ~ 繭窪憲糧鏇構觸構壓醖) 更多	-	2014-02-07
				Influenza A (H5N1) Virus Monovalent Vaccine (Influenza A (H5N1) 2 Group)	餘繭襯鹹餘糧網築繭夢(衊積構齋膚觸選鑰遞網) = 獵鬱窪壓憲鑰艱獵壓窪餘齋選窪壓淵遞鹽選鹹 (衊齋獵製壓鏇顧遞網窪, 壓襯夢願壓範蓋膚襯遞 ~ 壓範壓廠鏇構構構鬱簾) 更多