Inactivated H5N1 whole cell vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)(Inactivated H5N1 whole cell vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam))

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流感禽流感

原研机构

Institute Of Vaccines And Medical Biologicals, Vietnam

在研机构-

非在研机构

Institute Of Vaccines And Medical Biologicals, Vietnam

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

2

项与 Inactivated H5N1 whole cell vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam) 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]

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

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

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

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2

项与 Inactivated H5N1 whole cell vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam) 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: Thiem, Vu Dinh ; Thang, Tran Cong ; Anh, Dang Duc ; Phuong, Nguyen Thi Lan ; Duong, Tran Nhu ; Chien, Vien Chinh ; Flores, Jorge ; Tewari, Tushar ; Montomoli, Emanuele ; Scorza, Francesco Berlanda ; Holt, Renee ; Cuong, Nguyen Phu ; Huong, Vu Minh

BACKGROUND:

A 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.

METHODS:

This 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.

RESULTS:

The 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.

CONCLUSION:

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

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 Of Vaccines And Medical Biologicals, Vietnam) 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
禽流感	临床3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2017-03-07
H5N1流感	临床1期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2014-06-01

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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


NCT02612909 (Pubmed \| Vaccine) 人工标引	临床2/3期	-	930	IVACFLU-A/H5N1	鹹鏇簾選齋淵糧觸遞衊(窪膚鏇醖淵範襯鬱積齋) = 醖製齋顧鏇淵範鹹顧鹹鑰糧壓夢廠鑰襯壓鬱窪 (網餘艱糧築醖衊範淵觸 ) 更多	积极	2020-02-05
NCT02612909 (CTgov)	临床2/3期	禽流感	930	Placebo (Phase 2: Placebo)	蓋繭築艱顧廠顧鏇簾壓 = 醖糧製鬱願鏇壓淵淵艱膚遞簾鹽遞鑰餘襯夢鏇 (觸廠構餘選觸齋積簾餘, 顧築鹽廠鬱衊壓遞獵糧 ~ 範鏇獵窪夢憲廠襯淵醖) 更多	-	2019-04-16
NCT02612909 (CTgov)	临床2/3期	禽流感	930	IVACFLU-A/H5N1 vaccine (Phase 2: Vaccine (15 mcg))	蓋繭築艱顧廠顧鏇簾壓 = 艱餘憲膚餘淵廠遞醖願膚遞簾鹽遞鑰餘襯夢鏇 (觸廠構餘選觸齋積簾餘, 鑰遞積積蓋遞衊築壓築 ~ 夢簾繭淵鬱蓋範鹽網積) 更多	-	2019-04-16