更新于：2023-09-06
Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)
更新于：2023-09-06
概要
基本信息
药物类型 灭活疫苗、预防性疫苗 |
别名 split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)、pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)、Adjupanrix + [7] |
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 |
非在研机构- |
最高研发状态(全球)批准上市 |
首次获批日期(全球) 欧盟 (2009-10), 流感病毒感染 |
最高研发状态(中国)- |
特殊审评- |
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关联
16
项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的临床试验A phase II observer-blind, multicentre, dose-ranging study of children 6 to less than 36 months of age who are to be primed with a 2-dose series of GSK Biologicals’ AS03-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine. - FLU Q-PAN H5N1=AS03-023
Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)
Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years
100 项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的专利（医药）
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10
项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的文献（医药）2016-12-01International Journal of Biological Macromolecules1区 · 化学
Improvement of immune responses to influenza vaccine (H5N1) by sulfated yeast beta-glucan
1区 · 化学
Article
作者: Wang, Mi ; Zhang, Lifang ; Yang, Ruile ; Fei, Chenzhong ; Wang, Xiaoyang ; Zhang, Keyu ; Wang, Chunmei ; Zheng, Wenli ; Xue, Feiqun
In this study, the adjuvant activity of sulfated glucan from saccharomyces cerevisiae (SGSC) was investigated. sGSC had molecular weight of 12.9kDa and degrees of sulfation of 0.16. The effects of SGSC on the splenic lymphocyte cells of mice were measured in vitro. The results showed that SGSC could significantly promote lymphocyte proliferation singly or synergistically with Con A and LPS, and stimulate the cells to secrete IL-2 and INF-γ. The adjuvant activity of SGSC was researched in BALB/c mice inoculated with inactivated H5N1vaccine in vivo. The results showed that SGSC could significantly enhance lymphocyte proliferation, effectively increase the percentage of CD4+ T cells, decrease the percentage of CD8+ T cells, and elevate the CD4+/CD8+ ratio; enhance the HI antibody titre, and promote the production of IL-2, INF-γ, IL-4 and IL-6 at medium level. These results indicated that sulfated glucan showed an excellent adjuvant effect on H5N1vaccine in a mouse model. Therefore, SGSC could be used as an effective immune adjuvant for an inactivated H5N1vaccine.
2016-05-01Virology3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: Liu, Feng ; Sun, Xiangjie ; Fairman, Jeffery ; Lewis, David B. ; Katz, Jacqueline M. ; Levine, Min ; Tumpey, Terrence M. ; Lu, Xiuhua
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.
2015-01-01PLoS One3区 · 综合性期刊
Matrix M H5N1 vaccine induces cross-h5 clade humoral immune responses in a randomized clinical trial and provides protection from highly pathogenic influenza challenge in ferrets
3区 · 综合性期刊
ArticleOA
作者: Cox, Rebecca J. ; Major, Diane ; Pedersen, Gabriel ; Pathirana, Rishi D. ; Hoschler, Katja ; Guilfoyle, Kate ; Roseby, Sarah ; Bredholt, Geir ; Assmus, Jorg ; Breakwell, Lucy ; Campitelli, Laura ; Sjursen, Haakon
BACKGROUND AND METHODS:
Highly pathogenic avian influenza (HPAI) viruses constitute a pandemic threat and the development of effective vaccines is a global priority. Sixty adults were recruited into a randomized clinical trial and were intramuscularly immunized with two virosomal vaccine H5N1 (NIBRG-14) doses (21 days apart) of 30 μg HA alone or 1.5, 7.5 or 30 μg HA adjuvanted with Matrix M. The kinetics and longevity of the serological responses against NIBRG-14 were determined by haemagglutination inhibition (HI), single radial haemolysis (SRH), microneutralization (MN) and ELISA assays. The cross-H5 clade responses in sera were determined by HI and the antibody-secreting (ASC) cell ELISPOT assays. The protective efficacy of the vaccine against homologous HPAI challenge was evaluated in ferrets.
RESULTS:
The serological responses against the homologous and cross-reactive strains generally peaked one week after the second dose, and formulation with Matrix M augmented the responses. The NIBRG-14-specific seroprotection rates fell significantly by six months and were low against cross-reactive strains although the adjuvant appeared to prolong the longevity of the protective responses in some subjects. By 12 months post-vaccination, nearly all vaccinees had NIBRG-14-specific antibody titres below the protective thresholds. The Matrix M adjuvant was shown to greatly improve ASC and serum IgG responses following vaccination. In a HPAI ferret challenge model, the vaccine protected the animals from febrile responses, severe weight loss and local and systemic spread of the virus.
CONCLUSION:
Our findings show that the Matrix M-adjuvanted virosomal H5N1 vaccine is a promising pre-pandemic vaccine candidate.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00868218.
2
项与 Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) 相关的新闻（医药）2023-07-25
·靶点社
核酸药物信使RNA疫苗siRNA寡核苷酸
外链
| KEGG | Wiki | ATC | Drug Bank |
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| - | Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) | - |
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 | 欧盟 更多 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 312 | (Influenza A (H5N1) 1 Group) | 襯鬱觸憲衊襯鏇糧夢壓(選選餘壓選醖餘夢製膚) = 廠醖觸製窪襯艱願艱簾 鑰襯網蓋壓鹽蓋蓋鹹築 (膚醖鹽繭壓餘鬱網範鹹, 襯製範窪壓淵獵選糧鏇 ~ 繭淵膚鹹膚壓蓋憲構鹹) 更多 | - | 2014-02-07 | ||
(Influenza A (H5N1) 2 Group) | 襯鬱觸憲衊襯鏇糧夢壓(選選餘壓選醖餘夢製膚) = 遞鏇廠醖艱糧觸構網鑰 鑰襯網蓋壓鹽蓋蓋鹹築 (膚醖鹽繭壓餘鬱網範鹹, 網壓衊範鑰鬱顧鏇壓鏇 ~ 鹽鏇繭築簾築淵網餘艱) 更多 | ||||||
临床2期 | 50 | (Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant) | 網衊餘醖鹽築廠簾餘齋(窪積蓋選願衊鏇遞廠願) = 膚餘積製艱糧範鑰淵蓋 鑰繭鏇繭襯範構廠醖鏇 (膚醖鬱網艱齋襯醖獵廠, 夢鏇淵鹽膚餘觸積獵繭 ~ 簾鏇顧餘壓齋艱簾齋選) 更多 | - | 2019-02-12 | ||
AS03 (Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv) | 網衊餘醖鹽築廠簾餘齋(窪積蓋選願衊鏇遞廠願) = 鏇鹽淵衊鬱鹹願廠繭鹹 鑰繭鏇繭襯範構廠醖鏇 (膚醖鬱網艱齋襯醖獵廠, 襯遞鏇網築鏇觸衊糧築 ~ 網壓蓋膚遞顧餘選鏇憲) 更多 |
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