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

Purified Vi Polysaccharide Typhoid Vaccine、Typhoid vaccine Vi polysaccharide、SP093

+ [2]

靶点-

作用机制

免疫刺激剂

治疗领域

感染其他疾病

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 PasteurSanofi KK

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

13

项与伤寒Vi多糖疫苗(Sanofi) 相关的临床试验

NCT05919472 / RecruitingN/AIIT

Effects of Oral Iron Supplementation Before vs. at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women

Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle- income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.
The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).
We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson & Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.

开始日期2023-07-01

申办/合作机构

Jomo Kenyatta University of Agriculture & Technology

[+2]

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IIT

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-

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

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.

2024-12-01·VACCINE

A randomized, triple-blinded, placebo-controlled clinical trial evaluating immune responses of Typhim Vi and PPSV23 vaccines in healthy adults: The PREP study

Article

作者: McFarlane, Daniel ; Conroy, Bryan ; Cote, Gerard L ; Deutz, Nicolaas E P ; Damiano, Robert J. ; Silva, Ikaro ; Engelen, Mariёlle P K J ; Ruebush, Laura E. ; Wang, Chunxue ; Engelen, Mariёlle P.K.J. ; Mariani, Sara ; Deutz, Nicolaas E.P. ; Liu, Luoluo ; Ruebush, Laura E ; Borhani, Soheil ; Cote, Gerard L. ; Damiano, Robert J

Rapid and early identification of emergent infections is essential for delivering prompt clinical care. To advance the development of algorithms for the clinical management of infection identification, we performed a vaccination clinical trial to investigate the potential of using vaccination as a model for studying mild inflammation responses associated with different infections (NCT05346302). We collected data at various time points over 4 weeks from blood samples, wearable devices, and questionnaires. Following a 2-week baseline period, 210 healthy participants, aged 18-40 years, were administered either a Pneumococcal Polysaccharide vaccine (PPSV23), Typhoid Vi Polysaccharide vaccine (Typhim Vi), or placebo. In longitudinal analyses of blood biomarkers, we found that CRP was significantly higher at 2 days post-vaccination, whereas basophils, IL-10, IL-12p40, and MIG were significantly higher at 7 days post-vaccination in the PPSV23 group compared to both other groups (all p < 0.05). MIP-1β was significantly lower in the PPSV23 group than in the placebo group, while monocytes and MPV were significantly lower in the Typhim Vi group than in the placebo group at 7 days post-vaccination (all p < 0.05). The PPSV3 group showed a higher inflammatory profile, suggesting that PPSV23 induces a stronger immune response compared to Typhim Vi. The distinct immune responses induced by the two vaccines indicate the potential for utilizing vaccines as models for studying inflammation responses associated with different infectious pathogens.

2024-06-01·Pulmonary therapy

Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study

Article

作者: Ong-Dela Cruz, Bernice ; Jones, Paul ; Weng, Stephen ; van Hasselt, James ; Casas, Alejandro ; Tombs, Lee ; Ramirez-Venegas, Alejandra ; Sayiner, Abdullah ; Levy, Gur ; Juthong, Siwasak ; Litewka, Diego ; Aggarwal, Bhumika ; Compton, Chris ; Gomes, Mauro

INTRODUCTION:

Despite the proven benefits of inhaled corticosteroid (ICS)-containing triple therapy for chronic obstructive pulmonary disease (COPD), clinicians limit patient exposure to ICS due to the risk of pneumonia. However, there are multiple factors associated with the risk of pneumonia in patients with COPD. This post hoc analysis of IMPACT trial data aims to set the risks associated with ICS into a context of specific patient-related factors that contribute to the risk of pneumonia.

METHODS:

The 52-week, double-blind IMPACT trial randomized patients with symptomatic COPD and ≥1 exacerbation in the prior year 2:2:1 to once-daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI), FF/VI or UMEC/VI. Annual rate of on-treatment pneumonias in the intent-to-treat population associated with age, body mass index (BMI), percent predicted forced expiratory volume in 1 s (FEV₁) and blood eosinophil count (BEC) was evaluated.

RESULTS:

This analysis revealed that the annual rate of pneumonia showed the lowest risk at the age of 50 years. The 95% confidence intervals (CI) between ICS-containing and non-ICS containing treatments diverged in ages > 63 years, suggesting a significantly increased ICS-related risk in older patients. In contrast, the annual rate of pneumonia rose in both groups below BMI of 22.5 kg/m², but above that, there was no relationship to pneumonia rate and no differential effect between the two groups. The relationship between BEC and pneumonia was flat up to > 300/µL cells with ICS-containing treatment and then rose. In contrast, the rate of pneumonia with non-ICS containing treatment appeared to increase at a lower level of BEC (~ 200/µL).

CONCLUSIONS:

There was little evidence of a differential effect of older age, lower BMI, lower FEV₁ and BEC on the pneumonia rate between ICS-containing and non-ICS containing treatments. This analysis points to the need for a balanced approach to risk versus benefit in the use of ICS-containing treatments in COPD.

CLINICAL TRIAL REGISTRATION:

IMPACT ClinicalTrials.gov number, NCT02164513.

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

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
伤寒	美国	Sanofi Pasteur	2000-02-04

未上市

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
日本脑炎	临床3期	捷克	Novartis Pharma AG	2011-11-01
日本脑炎	临床3期	德国	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
流行性脑脊髓膜炎	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
黄热病	临床3期	德国	Novartis Pharma AG	2011-11-01
慢性阻塞性肺疾病	临床1期	美国	GSK Plc	2012-12-17
重度抑郁症	临床1期	比利时	Janssen Pharmaceutical Unlimited Co.	2012-05-01

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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))	窪顧願鏇構夢齋鹽憲壓(鬱襯鬱糧遞製鬱繭鏇繭) = 鹹顧願築鹹襯壓壓遞醖膚餘齋壓鏇糧鹽鑰積餘 (餘壓廠選繭鏇壓鬱積餘, 艱鏇窪醖鹹簾網糧願淵 ~ 淵膚鹹壓鬱顧鏇簾繭範) 更多	-	2014-05-12
				Typhoid+Typhoid Vi Polysaccharide Vaccine (Dolescents (Group 2))	窪顧願鏇構夢齋鹽憲壓(鬱襯鬱糧遞製鬱繭鏇繭) = 選製願艱構範顧築鹽醖膚餘齋壓鏇糧鹽鑰積餘 (餘壓廠選繭鏇壓鬱積餘, 鏇膚遞蓋範廠淵積壓蓋 ~ 獵鹹構鏇蓋構築餘繭顧)