Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)(Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd))

概要

基本信息

药物类型

预防性疫苗

别名

PanBlok H7

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

权益机构-

最高研发阶段临床1/2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

4

项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 相关的临床试验

NCT05608005

/ Completed临床1/2期

A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older

VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.
The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.
The study duration for each participant will be approximately 13 months.

开始日期2022-11-03

申办/合作机构

Sanofi Pasteur SA

NCT03283319

/ Completed临床2期IIT

Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

开始日期2017-09-20

申办/合作机构

Biomedical Advanced Research and Development Authority (BARDA)

[+1]

NCT03038776

/ Completed临床1期

A Randomised, Controlled, Phase 1 Study in Healthy Adults to Evaluate the Immunogenicity and Safety of a Recombinant H7 Hemagglutinin Influenza Vaccine

Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine, namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine

开始日期2017-01-01

申办/合作机构

Vaxine Pty Ltd.

100 项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 相关的临床结果

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100 项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 相关的转化医学

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100 项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 相关的专利（医药）

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1

项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 相关的文献（医药）

npj Vaccines1区 · 医学

Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults

1区 · 医学

ArticleOA

作者: Oshansky, Christine M ; Johnson, Robert A ; Cioce, Vittoria ; Lu, Di ; Chen, Li-Mei ; Horwith, Gary ; Jepson, Brett ; Treanor, John J ; Donis, Ruben O ; Pavetto, Corrina ; Zhou, James ; Bright, Rick A ; Nguyen, Bai ; King, James ; Biscardi, Karen

AbstractAn unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016–2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on the findings of a clinical study in healthy adults designed to evaluate the safety and immunogenicity of three dose levels of recombinant influenza vaccine derived from highly pathogenic A/Guangdong/17SF003/2016 (H7N9) virus adjuvanted with AS03 or MF59 oil-in water emulsions. Most of the six study groups meet the FDA CBER-specified vaccine licensure criterion of 70% seroprotection rate (SPR) for hemagglutination inhibition antibodies to the homologous virus. A substantial proportion of subjects show high cross-reactivity to antigenically distinct heterologous A(H7N9) viruses from the first epidemic wave of 2013. These results provide critical information to develop a pandemic response strategy and support regulatory requirements for vaccination under Emergency Use Authorization.

100 项与 Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) 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	药物发现	美国	Rho, Inc.	2017-09-20
禽流感	药物发现	澳大利亚	Vaxine Pty Ltd.	2017-01-01

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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


NCT05608005 (CTgov)	临床1/2期	流感病毒感染	581	Panblok H7+MF59 (Group 1: Panblok H7 (7.5 mcg) + MF59)	積選觸積顧淵鬱窪壓襯(繭糧醖淵積鬱製簾襯窪) = 鏇選鬱鹹鹽衊鏇製遞構繭繭製齋鏇製鹹鑰鏇鹹 (鹽遞簾築鏇襯夢範齋獵, 獵觸夢衊壓淵蓋鑰簾窪 ~ 繭觸艱積壓築襯築築獵) 更多	-	2025-02-20
				Panblok H7+MF59 (Group 2: Panblok H7 (15 mcg) + MF59)	積選觸積顧淵鬱窪壓襯(繭糧醖淵積鬱製簾襯窪) = 壓繭廠獵餘構艱襯膚網繭繭製齋鏇製鹹鑰鏇鹹 (鹽遞簾築鏇襯夢範齋獵, 夢觸網觸夢鏇鹹遞鬱構 ~ 範構齋簾淵夢窪鑰網鹽) 更多
NCT02464163 (PSC26, CTgov)	临床1/2期	流感病毒感染	407	Panblok+rHA adjuvant (Panblok 7.5µg in 2% SE)	壓鬱膚顧製積鬱鏇憲蓋(壓襯鹽衊壓艱鑰獵構膚) = 餘鬱築觸鹹鑰廠簾簾簾積築網蓋製願壓齋繭範 (蓋艱觸壓範壓廠衊鏇築, 範繭齋憲顧憲製繭觸齋 ~ 膚艱選餘膚齋衊衊選製) 更多	-	2017-10-26
				Panblok+rHA adjuvant (Panblok 15µg in 2% SE)	壓鬱膚顧製積鬱鏇憲蓋(壓襯鹽衊壓艱鑰獵構膚) = 鹹醖願遞簾糧製構鹹衊積築網蓋製願壓齋繭範 (蓋艱觸壓範壓廠衊鏇築, 艱糧齋壓廠範艱鹽製鹹 ~ 醖窪鬱顧壓壓蓋淵製鹹) 更多