Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals)(Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

IVACFLU-A

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-

非在研适应症

H5N1流感甲型流感病毒感染流感病毒感染

原研机构

Institute Vaccines Medical Biologicals

在研机构-

非在研机构

Institute Of Vaccines And Medical Biologicals, VietnamInstitute Vaccines Medical Biologicals

权益机构-

最高研发阶段无进展临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的临床试验

NCT02612909

/ Completed临床2/3期

A Phase 2/3 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

开始日期2017-03-07

申办/合作机构

Institute Of Vaccines And Medical Biologicals, Vietnam

[+5]

NCT02171819

/ Completed临床1期

A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

开始日期2014-06-01

申办/合作机构

Institute Of Vaccines And Medical Biologicals, Vietnam

[+4]

NCT01507779

/ Completed临床1期IIT

Evaluation of The Safety and Immunogenicity of an Influenza A/H1N1 Vaccine (IVACFLU), Produced by IVAC, in Healthy Adults in Vietnam

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.

开始日期2012-04-01

申办/合作机构

Program for Appropriate Technology in Health

[+2]

100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的临床结果

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100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的转化医学

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100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的专利（医药）

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2

项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的文献（医药）

2020-02-01·Vaccine

A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1)

Article

作者: Flores, Jorge ; Thiem, Vu Dinh ; Cuong, Nguyen Phu ; Phuong, Nguyen Thi Lan ; Holt, Renee ; Montomoli, Emanuele ; Anh, Dang Duc ; Scorza, Francesco Berlanda ; Tewari, Tushar ; Huong, Vu Minh ; Thang, Tran Cong ; Chien, Vien Chinh ; Duong, Tran Nhu

BACKGROUNDA global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development of a pre-pandemic influenza vaccine was initiated in 2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam.METHODSThis was a Phase 2/3, double-blinded, randomized, placebo-controlled study to test the safety and immunogenicity of IVACFLU-A/H5N1 vaccine in healthy adults. Phase 2 was a dose selection study, in which 300 participants were randomized to one of the three groups (15 mcg, 30 mcg, or placebo). Safety and immunogenicity were assessed in all participants. In Phase 3, 630 participants were randomized to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 (15 mcg, n = 525) or placebo (n = 105). Safety was assessed in all Phase 3 participants and immunogenicity was measured in a subset of participants.RESULTSThe vaccine was well tolerated and most of the adverse events were mild and of short duration. Mild pain at the injection site was the most common adverse event seen in 60 percent of participants in the vaccine group in Phase 3. In Phase 2, both 15 mcg and 30 mcg doses were immunogenic, so the lower dose was selected for further testing in Phase 3. In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH). The seroprotection rates were 44 percent for HI, 41 percent for MN and 55 percent for SRH. The GMT ratio was 5.31 and 3.7 for HI and MN respectively; GMA was 4.75 for the SRH.CONCLUSIONThe IVACFLU A/H5N1 was safe and immunogenic. Development of this pandemic avian influenza vaccine is a welcome addition to the limited global pool of these vaccines. ClinicalTrials.gov register NCT02612909.

2010-12-01·Vaccine3区 · 医学

Evaluation of the cellular immune responses induced by a non-adjuvanted inactivated whole virus A/H5N1/VN/1203 pandemic influenza vaccine in humans

3区 · 医学

Article

作者: Brian A. Crowe ; Gerald Aichinger ; P. Noel Barrett ; Hartmut Ehrlich ; Julia Singer ; Markus Müller ; Michael G. Schwendinger ; Katrin Koelling-Schlebusch ; Peter Brühl ; Markus Zeitlinger ; Otfried Kistner ; Andreas Pilz ; Marijan Gerencer

In the present study the homologous and heterologous type and subtype specific cellular immune response induced by a wild type inactivated whole virus H5N1 Influenza (A/Vietnam/1203/2004) vaccine was evaluated. Two immunizations with the Vero cell derived H5N1 influenza vaccine on Day 0 and Day 21 induced significant H5N1 vaccine specific and H5 haemagglutinin specific clade and cross-clade reactive CD4(+) T cell responses, which were maintained at significant levels for at least 6 months. The H5N1 vaccine specific response cross-reacted with the H1N1, but not with H3N2 or B seasonal Influenza strains. The vaccine significantly increased the number of H5N1 specific and H5 haemagglutinin specific memory B cells, 6 months after the primary immunization, however no H1N1 specific cross-reactivity was observed. Importantly, the inactivated whole virus H5N1 vaccine was just as effective in inducing CD4(+) T cell and memory B cell response in the elderly (60 years or over) as in the adult population (18-59 years).

100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的药物交易

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研发状态

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3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2017-03-07
H5N1流感	临床3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2014-06-01
甲型流感病毒感染	临床3期	-	Institute Vaccines Medical Biologicals	-

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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


NCT02612909 (Pubmed \| Vaccine) 人工标引	临床2/3期	-	930	IVACFLU-A/H5N1	糧鹽糧壓鬱鹽蓋簾顧遞(範艱鏇醖積襯範齋構遞) = 鑰膚觸範顧築憲遞鬱獵襯膚網鑰壓襯構鹽膚網 (築膚選廠獵衊遞齋膚遞 ) 更多	积极	2020-02-05
NCT02612909 (CTgov)	临床2/3期	禽流感 \| 流感病毒感染	930	Placebo (Phase 2: Placebo)	選蓋鑰積壓蓋糧積鑰餘(夢選顧壓選遞網艱築鹹) = 願憲夢醖製壓襯獵觸網廠選憲觸遞襯範糧蓋廠 (襯鬱餘獵觸齋獵願餘廠, 鏇糧築遞蓋繭範積選觸 ~ 願餘鑰夢選獵觸鹽齋衊) 更多	-	2019-04-16
				IVACFLU-A/H5N1 vaccine (Phase 2: Vaccine (15 mcg))	選蓋鑰積壓蓋糧積鑰餘(夢選顧壓選遞網艱築鹹) = 鑰艱積窪淵鬱蓋鏇憲積廠選憲觸遞襯範糧蓋廠 (襯鬱餘獵觸齋獵願餘廠, 鏇顧鬱廠醖糧淵淵製糧 ~ 鹽夢壓繭醖夢積選構淵) 更多
NCT01507779 (CTgov)	临床1期	甲型流感病毒感染	48	Placebo (Placebo)	鏇鬱顧鏇衊積網願積窪(願憲網廠襯製餘選夢艱) = 築願壓繭膚鑰繭鏇構窪網餘壓觸艱艱鬱憲鏇憲 (願壓繭觸糧窪顧膚餘範, 網觸餘鏇簾繭積繭鹽積 ~ 顧獵繭廠窪製顧窪鏇鑰) 更多	-	2019-02-27
				IVACFLU (Influenza Vaccine)	鏇鬱顧鏇衊積網願積窪(願憲網廠襯製餘選夢艱) = 艱觸夢壓網鏇顧顧構簾網餘壓觸艱艱鬱憲鏇憲 (願壓繭觸糧窪顧膚餘範, 範鬱鹽鬱簾顧簾鹹願積 ~ 鹹鏇遞衊艱醖鏇鏇網襯) 更多