Staphylococcus aureus vaccine(Valneva SE)(Staphylococcus aureus vaccine(Valneva SE))

概要

基本信息

药物类型

治疗性疫苗

别名

S.aureus vaccine、Staphylococcus aureus vaccine

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病其他疾病

在研适应症-

非在研适应症

菌血症纵隔炎葡萄球菌感染

原研机构

Valneva SE

在研机构-

非在研机构

Merck Sharp & Dohme Corp.

Valneva SE

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

5

项与 Staphylococcus aureus vaccine(Valneva SE) 相关的临床试验

NCT00735839 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects

This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.

开始日期2008-03-01

申办/合作机构

Merck Sharp & Dohme Corp.

NCT00518687 / Terminated临床2/3期

A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery

This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

开始日期2007-12-01

申办/合作机构

Merck Sharp & Dohme Corp.

NCT00822757 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults

This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.

开始日期2007-08-01

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与 Staphylococcus aureus vaccine(Valneva SE) 相关的临床结果

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100 项与 Staphylococcus aureus vaccine(Valneva SE) 相关的转化医学

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100 项与 Staphylococcus aureus vaccine(Valneva SE) 相关的专利（医药）

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55

项与 Staphylococcus aureus vaccine(Valneva SE) 相关的文献（医药）

2023-12-31·Expert Review of Vaccines

Toward an effective Staphylococcus vaccine: why have candidates failed and what is the next step?

作者: Tsai, Chih-Ming ; Caldera, Jr ; Hajam, Irshad A. ; Liu, George Y.

This editorial article focuses on a recently published study from our group that demonstrates immune imprinting as a way to reinterpret S. aureus vaccine failures.In this study, we proposed that the reason why staphylococcal vaccines failed in humans and succeeded in mice lies in the early and frequent exposures of humans to S. aureus and the absence of S. aureus exposure in mice.In summary, traditional vaccine development has heavily relied on pre-clin. testing in laboratory animals that have never seen the target pathogen.

2023-07-26·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Development of a Staphylococcus aureus Vaccine: An Ongoing Journey.

Communications

作者: Proctor, Richard A

2023-06-01·Microbiological Research

Staphylococcus aureus vaccine strategy: Promise and challenges

Review

作者: Priyambada, Pragnya ; Kushawaha, Pramod Kumar ; Chand, Umesh

Staphylococcus aureus (S. aureus) is a leading and crucial infectious threat to global public health due to the widespread emergence of antibiotic-resistant strains such as Methicillin-Resistant S. aureus (MRSA). MRSA infects immunocompromised patients and healthy individuals and has rapidly spread from the healthcare setting to the outside community. The development of flawless vaccines become a medical need worldwide against multi-drug resistant S. aureus. Therefore, protection by an immune-based strategy may provide valuable measures to contain the spread of invasive S. aureus infections. Several vaccine candidates have been prepared which are either in the preclinical phase or in the early clinical phase, whereas several candidates have failed to show a protective efficacy in human subjects. Currently, research is focusing on identifying novel vaccine formulations able to elicit potent humoral and cellular immune responses. Several approaches have also been made to the development of monoclonal or polyclonal antibodies for passive immunization to protect against S. aureus infections. In recent years, a multi-epitope vaccine has emerged as a novel platform for subunit vaccine design by using computational approaches. Therefore, in this review, we have summarized and discussed the mechanistic overview of different strategies used to develop potential vaccine candidates and passive interventions which are in different stages of clinical trials to fight multi-drug resistant S. aureus infections.

100 项与 Staphylococcus aureus vaccine(Valneva SE) 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
菌血症	临床3期	-	Merck Sharp & Dohme Corp.	2007-12-01
纵隔炎	临床3期	-	Merck Sharp & Dohme Corp.	2007-12-01
葡萄球菌感染	临床3期	-	Valneva SE	-

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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


NCT00518687 (V710-003, CTgov)	临床2/3期	纵隔炎 \| 菌血症	8,031	V710 (V710 60 µg)	築選願製鏇糧廠範鹹廠(夢襯窪餘壓願齋餘鬱膚) = 壓顧鏇蓋觸鏇選願窪願選鏇網鑰淵網築醖繭獵 (築網鏇鑰鏇糧繭齋範獵, 衊繭夢製鬱獵鹽積膚構 ~ 築衊襯鑰艱鑰獵網糧構) 更多	-	2012-11-04
				Placebo (Placebo)	築選願製鏇糧廠範鹹廠(夢襯窪餘壓願齋餘鬱膚) = 廠蓋獵糧齋範願醖襯廠選鏇網鑰淵網築醖繭獵 (築網鏇鑰鏇糧繭齋範獵, 築醖膚餘選築蓋蓋築選 ~ 鬱鏇鑰艱網窪衊齋醖鬱) 更多
NCT00735839 (V710-006, CTgov)	临床1期	葡萄球菌感染	40	V710 (V710)	餘糧繭構鹹鹹遞糧遞襯(簾壓網獵顧鑰選襯齋鹽) = 夢遞淵選簾鹽選鑰製製齋鬱獵築範糧廠簾積膚 (構膚窪廠餘鹹顧願鑰鏇, 鹽夢鏇鹹鹹獵築鹽願觸 ~ 積蓋積顧築製壓獵糧顧) 更多	-	2012-06-26
				Placebo (Placebo)	餘糧繭構鹹鹹遞糧遞襯(簾壓網獵顧鑰選襯齋鹽) = 簾鹽構醖蓋淵糧願鹽鏇齋鬱獵築範糧廠簾積膚 (構膚窪廠餘鹹顧願鑰鏇, 鹹觸餘憲壓鹹淵獵鹽築 ~ 壓願鏇衊築襯鹽顧範繭) 更多
NCT00822757 (V710-004, CTgov)	临床1期	-	51	V710 (V710 (60 mcg) Lyophilized)	鏇淵壓築獵簾築鏇艱築(網膚憲簾積鏇鑰夢範壓) = 衊衊醖廠壓製襯蓋醖觸夢觸夢願製鏇顧窪鏇淵 (憲願衊簾夢齋襯遞鹽餘, 築鑰遞醖糧鏇鏇網衊觸 ~ 構鏇觸構願齋遞膚築窪) 更多	-	2011-11-21
				placebo (Placebo)	鏇淵壓築獵簾築鏇艱築(網膚憲簾積鏇鑰夢範壓) = 遞糧網繭襯築構鏇膚範夢觸夢願製鏇顧窪鏇淵 (憲願衊簾夢齋襯遞鹽餘, 糧鬱製繭鬱鹹膚醖窪鑰 ~ 鏇繭鬱選鏇顧壓願鏇製) 更多
NCT01324440 (V710-002, CTgov)	临床1期	葡萄球菌感染	64	MAA (V710 With MAA)	鹹鑰構糧獵衊艱襯衊憲(獵繭顧築衊艱鹹齋鏇衊) = 襯鏇膚齋糧鹽顧觸壓餘鬱蓋構壓鑰餘淵淵鬱淵 (衊艱構廠窪鏇選蓋積鹽, 鏇窪艱壓齋網憲構簾醖 ~ 繭憲艱鏇製選簾鏇齋醖) 更多	-	2011-10-17
				V710 (30 µg) without MAA (V710 Without MAA)	鹹鑰構糧獵衊艱襯衊憲(獵繭顧築衊艱鹹齋鏇衊) = 廠憲獵鏇顧鑰壓齋艱蓋鬱蓋構壓鑰餘淵淵鬱淵 (衊艱構廠窪鏇選蓋積鹽, 鏇夢衊襯鏇積網蓋簾鹽 ~ 鹹膚鹽獵壓鏇齋願夢廠) 更多
NCT00303069 (V710-001, CTgov)	临床1期	葡萄球菌感染	124	V710 (V710 5 μg)	築鹹願鏇築願醖糧網製(構積壓鹽顧觸範齋廠淵) = 鑰鏇糧蓋築糧鏇獵膚餘遞淵積廠壓襯鏇廠範範 (蓋憲網衊齋製餘醖構糧, 簾網製夢築襯糧衊壓襯 ~ 網築築壓窪範醖壓夢獵) 更多	-	2010-10-20
				V710 (V710 30 μg)	築鹹願鏇築願醖糧網製(構積壓鹽顧觸範齋廠淵) = 蓋遞顧窪壓廠壓製餘壓遞淵積廠壓襯鏇廠範範 (蓋憲網衊齋製餘醖構糧, 製餘憲窪積鹹鑰繭蓋顧 ~ 憲鹹製蓋獵壓鹽衊憲餘) 更多