Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)(Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences))

概要

基本信息

药物类型

预防性疫苗

别名

GPO Avian Flu Vaccine、Influenza A virus vaccine H5N2 intranasal、Intranasal H5N2 vaccine

+ [4]

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

流感病毒感染

非在研适应症-

原研机构

Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences

在研机构

Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2012-11-28),

流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的临床试验

NCT02153671

/ Completed临床2期IIT

Immunogenicity of OrniFlu® Inactivated Influenza Vaccine in Subjects Previously Immunized With Live Attenuated H5N2 Influenza Vaccine and in Non-vaccinated Subjects

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

开始日期2014-05-01

申办/合作机构

Program for Appropriate Technology in Health

[+2]

NCT01982331

/ Completed临床1期IIT

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

开始日期2013-10-01

申办/合作机构

Program for Appropriate Technology in Health

[+2]

NCT01719783

/ Completed临床1期IIT

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.

开始日期2012-09-01

申办/合作机构

Program for Appropriate Technology in Health

[+2]

100 项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的临床结果

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100 项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的转化医学

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100 项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的专利（医药）

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1

项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的文献（医药）

2017-08-01·The Lancet Infectious Diseases1区 · 医学

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial

1区 · 医学

Article

作者: Sparrow, Erin ; Boonnak, Kobporn ; Puthavathana, Pilaipan ; Wirachwong, Ponthip ; Chamnanchanunt, Supat ; Friede, Martin ; Silachamroon, Udomsak ; Pitisuttithum, Punnee ; Rudenko, Larisa ; Lawpoolsri, Saranath ; Schuetz, Alexandra ; Luvira, Viravarn ; Kieny, Marie-Paule ; Lerdsamran, Hatairat ; Thanachartwet, Vipa ; Masamae, Wanibtisam ; Thirapakpoomanunt, Sit ; Kaewkungwal, Jaranit

BACKGROUNDThe emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost.METHODSThis study was done at the Vaccine Trial Centre at Mahidol University, Bangkok, Thailand and was divided into two parts. Part 1 consisted of a randomised, double-blind, placebo-controlled trial done over 18 months. We randomly assigned (2:1) healthy Thai adults aged 18-49 years with a computer generated randomisation sequence (blocks of six) to receive either two intranasal doses (0·25 mL per nostril) of LAIV H5N2 (101 participants) or placebo (51 participants) 21 days apart. For part 2, an open-label trial was done in which previously vaccinated participants (40 from LAIV H5N2 group and 20 placebo) were given one intramuscular dose (0·5 mL) of H5N1 booster vaccine. Participants, investigators, and site-study workers were blinded from randomisation. Immune responses after subsequent immunisation were evaluated using haemagglutination-inhibition and microneutralisation assays and circulating follicular T-helper cells and plasmablast cells were measured in serum and whole blood. The trials are registered with ClinicalTrials.gov, numbers NCT01841918 and NCT02229357.FINDINGSBetween Feb 4, 2013, and Feb 28, 2013, 256 individuals were screened, of whom 152 participants were enrolled in part 1 of this study. LAIV H5N2 vaccine was well tolerated. Viral shedding was detected in only six (6%) of 101 participants in the vaccine group 1 day after the first vaccination and in and two (2%) of 98 participants in the group after the second vaccination. There was no serious adverse event in both groups. 51 (50%) of 101 participants in the vaccine group and 28 (55%) of 51 in the placebo group reported at least one adverse event. 80 (84%) of 95 events in the vaccine group and 32 (78%) of 43 events in the placebo groups were reportedly suspected adverse events, probably related to the vaccine; however, most were mild in nature. After two doses of vaccine, 13 (13%) of 100 participants in the vaccine group had an increase in haemagglutination-inhibition titre of more than four-fold and four (4%) of 100 vaccinees developed a rise in neutralisng antibody titre of more than four-fold. 1 year later, after a booster with an inactivated H5N1 vaccine (part 2), 39 (98%) of 40 participants who had previously been vaccinated with LAIV H5N2 had an increase in haemagglutination-inhibition titre of greater than four-fold as early as day 7 compared with three (15%) of 20 participants in the placebo group. Peak geometric mean titre (GMT) for haemagglutination-inhibition antibodies in the previously LAIV H5N2 vaccinated group (566·89 [95% CI 436·97-735·44]) were significantly higher than among those who previously received placebo (25·49 [11·82-54·96]; p<0·0001). The peak GMT by neutralising antibody assay in the H5N2 vaccinated group (1395·85 [1040·79-1872·03]) was also significantly higher than that observed in the placebo group (17·41 [9·05-33·48]; p<0·0001). Importantly, higher cross-reactive haemagglutination-inhibition antibody titres against H5N1 (clades 1, 2.1.3.2, and 2.3.4) were detected in the LAIV H5N2 experienced group than the naive group (p<0·0001).INTERPRETATIONOur data suggest that LAIV vaccination induces long-lasting memory immune responses. The limitation of this study was that part 2 was designed as a proof-of-concept study by contrast with part 1.FUNDINGWHO.

100 项与 Influenza A virus vaccine H5N2 intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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	俄罗斯	Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences	2012-11-28

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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


NCT01982331 (CTgov)	临床1期	流感病毒感染	38	LAIV H2N2 (LAIV H2N2 Vaccine)	範窪壓夢顧遞餘鑰獵築(廠襯構範艱鏇構構淵觸) = 範選壓蓋壓觸糧鹹遞積膚壓憲鹽壓範觸遞廠築 (製鹹網網鏇廠簾鬱膚蓋, 醖艱築壓淵簾壓鑰鑰簾 ~ 築鹹齋築鹹蓋鏇鏇壓襯) 更多	-	2019-02-06
NCT01982331 (CTgov)	临床1期	流感病毒感染	38	Placebo (Placebo)	範窪壓夢顧遞餘鑰獵築(廠襯構範艱鏇構構淵觸) = 遞顧窪廠鬱鏇獵獵構鹽膚壓憲鹽壓範觸遞廠築 (製鹹網網鏇廠簾鬱膚蓋, 鏇鏇壓構獵構蓋膚夢製 ~ 糧網觸蓋鹽餘網糧糧鏇) 更多	-	2019-02-06
IAS2004	N/A	HIV感染	-	GPO-VIR	(構窪襯構顧淵壓範獵餘) = Adverse events (rash, hepatitis, and nausea/vomiting) were found in 13 (14%) patients. 構齋蓋膚窪蓋範襯艱願 (鏇鑰糧鏇築憲簾遞鑰鹽 )	-	2004-01-01