伤寒Vi多糖疫苗(Sanofi)(Typhoid Vi polysaccharide vaccine(Sanofi)) - 在研适应症：伤寒_专利_临床

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

Typhim Vi、Typhoid vaccine Vi polysaccharide

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

伤寒

非在研适应症

重度抑郁症日本脑炎流行性脑脊髓膜炎+ [2]

原研机构

Sanofi

在研机构

Sanofi Pasteur

非在研机构

GSK PlcNovartis Pharma AGJanssen Pharmaceutical Unlimited Co.

最高研发阶段批准上市

首次获批日期

美国 (2000-02-04),

伤寒

最高研发阶段(中国)批准上市

特殊审评-

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关联

12

项与伤寒Vi多糖疫苗(Sanofi) 相关的临床试验

NCT05346302 / Completed早期临床1期IIT

Persistent Readiness Through Early Prediction Immunization Study

This study will enroll volunteers in an open-format (outside hospital) setting, to complete novel data collection/analysis of biomarkers, facial images, and audio-recording to establish an optimal set of parameters to predict emergent cases of infection via an early warning score, along with actionable personalized information.

开始日期2022-02-08

申办/合作机构

Texas A&M University

[+1]

ACTRN12621001059853 / Active, not recruiting临床4期

Evaluating Vi-polysaccharide vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.

开始日期2022-01-18

申办/合作机构-

NCT03968211 / Completed临床1期IIT

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.

开始日期2019-07-01

申办/合作机构

University of Virginia

[+2]

100 项与伤寒Vi多糖疫苗(Sanofi) 相关的临床结果

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100 项与伤寒Vi多糖疫苗(Sanofi) 相关的转化医学

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100 项与伤寒Vi多糖疫苗(Sanofi) 相关的专利（医药）

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305

项与伤寒Vi多糖疫苗(Sanofi) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers

Article

作者: Tamrakar, Rajendra ; Gupta, Birendra Prasad ; Khadgi, Amit ; Tamrakar, Dipesh ; Shrestha, Anmol ; Rai, Ganesh Kumar ; Saluja, Tarun ; Thapa, Pragya ; Poudel, Pranodan ; Madhup, Surendra ; Singh, Srijana ; Shrestha, Rajeev ; Sahastrabuddhe, Sushant ; Thapa, Sameera

Typhoid fever is a significant public health concern with most of the sufferers between 15 and 25 y of age in Nepal. We undertook this study to demonstrate Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT) conjugate vaccine which is non-inferior to Typbar typhoid conjugate vaccine, a Vi polysaccharide vaccine conjugated with tetanus toxoid (Vi-TT) with a focus on the adult population from Dhulikhel Hospital which was one of the total four sites in Nepal. In this study, we assigned the eligible participants in 1:1:1:1 ratio by block randomization, and stratified into three age groups (6 months to less than 2 y, 2 y to less than 18 y, and 18 y to 45 y), allotted to Group A, B, C, and D. Group A, B, and C received 25 μg (0.5 mL) of Vi-DT study vaccine and participants in Group D received 25 μg (0.5 mL) Vi-TT vaccine. We descriptively analyzed safety in all the participants receiving one dose of the investigational vaccine. The anti-Vi-IgG seroconversion rate in Vi-DT recipients was 99.71% (97.5% CI 98.04-99.96; 344 of 345 participants) and 99.13% (94.27-99.87; 114 of 115) in Vi-TT recipients which indicates that Vi-DT vaccine is non-inferior to Vi-TT vaccine. In safety aspect, 16.81% of total subject had at least one solicited adverse reaction and 22.61% of the Vi-TT participants experienced at least one solicited adverse reaction with most of them being local adverse reactions. None of the enrolled participants reported serious adverse events. Our study shows that a single dose of the Vi-DT vaccine is immunogenic, safe to administer and non-inferior to the Vi-TT vaccine four weeks after vaccination.

2024-04-01·ImmunoHorizons

Monophosphoryl Lipid A–based Adjuvant to Promote the Immunogenicity of Multivalent Meningococcal Polysaccharide Conjugate Vaccines

Article

作者: Alugupalli, Kishore R

AbstractActivation of the adaptive immune system requires the engagement of costimulatory pathways in addition to B and T cell Ag receptor signaling, and adjuvants play a central role in this process. Many Gram-negative bacterial polysaccharide vaccines, including the tetravalent meningococcal conjugate vaccines (MCV4) and typhoid Vi polysaccharide vaccines, do not incorporate adjuvants. The immunogenicity of typhoid vaccines is due to the presence of associated TLR4 ligands in these vaccines. Because the immunogenicity of MCV4 is poor and requires boosters, I hypothesized that TLR4 ligands are absent in MCV4 and that incorporation of a TLR4 ligand–based adjuvant would improve their immunogenicity. Consistent with this hypothesis, two Food and Drug Administration–approved MCV4 vaccines, MENVEO and MenQuadfi, lack TLR4 ligands. Admixing monophosphoryl lipid A, a TLR4 ligand–based adjuvant formulation named “Turbo” with MCV4 induced significantly improved IgM and IgG responses to all four meningococcal serogroup polysaccharides in adult and aged mice after a single immunization. Furthermore, in infant mice, a single booster was sufficient to promote a robust IgG response and 100% seroconversion when MCV4 was adjuvanted with Turbo. Turbo upregulated the expression of the costimulatory molecules CD40 and CD86 on B cells, and Turbo-driven adjuvanticity is lost in mice deficient in CD40 and CD86. These data suggest that Turbo induces the required costimulatory molecules for its adjuvant activity and that incorporation of Turbo could make bacterial polysaccharide vaccines more immunogenic, minimize booster requirements, and be cost-effective, particularly for those individuals in low- and middle-income and disease-endemic countries.

2024-04-01·Journal of Hepatology

A novel treatment strategy utilizing panobinostat for high-risk and treatment-refractory hepatoblastoma

Article

作者: Srivastava, Rohit K ; Badachhape, Andrew A ; Dobrolecki, Lacey E ; Sumazin, Pavel ; Zorman, Barry ; Patel, Roma H ; Kats, Dina ; Whitlock, Richard ; Armbruster, Bryan ; Bissig, Karl-Dimiter ; López-Terrada, Dolores H ; Espinoza, Andres F ; Woodfield, Sarah E ; Kona, Abhishek ; Yu, Xinjian ; Kureti, Pavan ; Srinivasan, Ramakrishnan R ; Sarabia, Stephen F ; Duong, Ashley ; Keller, Charles ; Major, Angela ; Heczey, Andras ; Vasudevan, Sanjeev A ; Urbicain, Martin ; Najaf Panah, Mohammad J ; Patel, Kalyani R ; Lewis, Michael T ; Govindu, Saiabhiroop R

BACKGROUND & AIMSPatients with metastatic, treatment-refractory, and relapsed hepatoblastoma (HB) have survival rates of less than 50% due to limited treatment options. To develop new therapeutic strategies for these patients, our laboratory has developed a preclinical testing pipeline. Given that histone deacetylase (HDAC) inhibition has been proposed for HB, we hypothesized that we could find an effective combination treatment strategy utilizing HDAC inhibition.METHODSRNA sequencing, microarray, NanoString, and immunohistochemistry data of patient HB samples were analyzed for HDAC class expression. Patient-derived spheroids (PDSp) were used to screen combination chemotherapy with an HDAC inhibitor, panobinostat. Patient-derived xenograft (PDX) mouse models were developed and treated with the combination therapy that showed the highest efficacy in the PDSp drug screen.RESULTSHDAC RNA and protein expression were elevated in HB tumors compared to normal livers. Panobinostat (IC₅₀ of 0.013-0.059 μM) showed strong in vitro effects and was associated with lower cell viability than other HDAC inhibitors. PDSp demonstrated the highest level of cell death with combination treatment of vincristine/irinotecan/panobinostat (VIP). All four models responded to VIP therapy with a decrease in tumor size compared to placebo. After 6 weeks of treatment, two models demonstrated necrotic cell death, with lower Ki67 expression, decreased serum alpha fetoprotein and reduced tumor burden compared to paired VI- and placebo-treated groups.CONCLUSIONSUtilizing a preclinical HB pipeline, we demonstrate that panobinostat in combination with VI chemotherapy can induce an effective tumor response in models developed from patients with high-risk, relapsed, and treatment-refractory HB.IMPACT AND IMPLICATIONSPatients with treatment-refractory hepatoblastoma have limited treatment options with survival rates of less than 50%. Our manuscript demonstrates that combination therapy with vincristine, irinotecan, and panobinostat reduces the size of high-risk, relapsed, and treatment-refractory tumors. With this work we provide preclinical evidence to support utilizing this combination therapy as an arm in future clinical trials.

100 项与伤寒Vi多糖疫苗(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	伤寒Vi多糖疫苗(Sanofi)	J07AP03	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
伤寒	捷克	Sanofi Pasteur	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	临床3期	美国	GSK Plc	2012-12-17
重度抑郁症	临床3期	比利时	Janssen Pharmaceutical Unlimited Co.	2012-05-01
日本脑炎	临床3期	捷克	Novartis Pharma AG	2011-11-01
流行性脑脊髓膜炎	临床3期	捷克	Novartis Pharma AG	2011-11-01
黄热病	临床3期	德国	Novartis Pharma AG	2011-11-01
黄热病	临床3期	捷克	Novartis Pharma AG	2011-11-01
伤寒	临床1期	德国	Novartis Pharma AG	2011-11-01
日本脑炎	药物发现	德国	Novartis Pharma AG	2011-11-01
流行性脑脊髓膜炎	药物发现	德国	Novartis Pharma AG	2011-11-01

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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


NCT01608815 (CTgov)	临床3期	伤寒	200	Typhoid+Typhoid Vi Polysaccharide Vaccine (Adults (Group 1))	鏇蓋製簾鹽範積鏇鹽廠(壓選鏇夢積鏇觸網構壓) = 選選獵鬱夢鏇膚夢衊願繭膚餘遞繭鑰築鬱繭壓 (艱淵憲範淵淵網觸壓範, 築繭鬱鹽憲憲願鏇鏇積 ~ 觸鬱廠繭選膚窪顧構繭) 更多	-	2014-05-12
NCT01608815 (CTgov)	临床3期	伤寒	200	Typhoid+Typhoid Vi Polysaccharide Vaccine (Dolescents (Group 2))	鏇蓋製簾鹽範積鏇鹽廠(壓選鏇夢積鏇觸網構壓) = 簾鬱壓餘觸範顧顧築網繭膚餘遞繭鑰築鬱繭壓 (艱淵憲範淵淵網觸壓範, 鬱鏇遞壓遞鹹夢鹽觸衊 ~ 齋衊構膚範艱鹽鑰壓鏇)	-	2014-05-12
NCT01193907 (CTgov)	临床2期	伤寒	88	Vi-polysaccharide vaccine	夢夢網簾餘餘築鏇齋壓(蓋製夢範選範網範築餘) = 鹹選範觸壓醖餘獵觸廠衊夢選窪網廠築廠構築 (糧構簾憲淵憲構夢蓋鏇, 範糧繭艱鬱選繭糧鏇選 ~ 願築鏇鑰餘積窪構願淵) 更多	-	2012-04-03