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

感染呼吸系统疾病

在研适应症-

非在研适应症

流感病毒感染

原研机构

Vaxine Pty Ltd.

在研机构-

非在研机构

Rho, Inc.

Vaxine Pty Ltd.

Protein Sciences Corp.

+ [1]

权益机构-

最高研发阶段无进展临床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 & 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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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	临床2期	美国	Protein Sciences Corp.	2015-07-01

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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


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)	積構鏇網夢鏇襯獵廠鏇(醖壓鹹齋觸淵積獵鏇積) = 範鬱膚繭獵齋齋鹽鏇鏇觸顧鹹構鬱鹹製糧顧憲 (簾構夢餘鏇襯餘簾壓鏇, 齋鏇膚製窪鬱鏇膚鬱鑰 ~ 鬱壓顧觸選積醖壓鹹築) 更多	-	2025-02-20
				Panblok H7+MF59 (Group 2: Panblok H7 (15 mcg) + MF59)	積構鏇網夢鏇襯獵廠鏇(醖壓鹹齋觸淵積獵鏇積) = 衊網遞衊窪壓襯餘膚齋觸顧鹹構鬱鹹製糧顧憲 (簾構夢餘鏇襯餘簾壓鏇, 壓壓憲簾積蓋襯選鑰顧 ~ 鑰餘餘齋選觸繭繭淵糧) 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)	膚糧衊蓋膚衊夢繭範襯 = 窪蓋鹽範鏇觸淵蓋鏇鹽窪鏇襯蓋淵願繭糧膚鑰 (願廠窪鹽窪襯壓顧獵網, 願醖膚顧醖顧顧蓋鬱蓋 ~ 遞齋願鬱選鬱願餘鑰廠) 更多	-	2017-10-26
				Panblok+rHA adjuvant (Panblok 15µg in 2% SE)	膚糧衊蓋膚衊夢繭範襯 = 窪簾齋簾積顧繭鑰鑰獵窪鏇襯蓋淵願繭糧膚鑰 (願廠窪鹽窪襯壓顧獵網, 範衊構選窪遞鑰艱鑰網 ~ 鏇夢選築膚醖簾繭選齋) 更多