(CYD Dengue Vaccine (sanofi)) - _专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

Live, attenuated, recombinant dengue、CYD Dengue Vaccine

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-

非在研适应症

登革热严重登革热黄热病

原研机构

Sanofi

在研机构-

非在研机构

Sanofi Pasteur

Sanofi

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-

关联

10

项与 CYD Dengue Vaccine (sanofi) 相关的临床试验

NCT02741128 / Completed临床2期

Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil

The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue.
Primary Objective:
To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.
Secondary Objectives:
To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.
To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue.
To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.
Observational Objective:
To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.

开始日期2019-10-28

申办/合作机构

Sanofi Pasteur

NCT02992418 / Terminated临床3期

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines

The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially.
Primary Objectives:
To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose.
To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine.
Secondary Objectives:
To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine.
To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group.
To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group.
To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.

开始日期2016-12-19

申办/合作机构

Sanofi Pasteur

NCT02993757 / Completed临床3期

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant) when administered concomitantly or sequentially.
Primary objectives:
To demonstrate that the humoral immune response (in terms of geometric mean titers [GMTs]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.
To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine.
Secondary Objectives:
To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.
To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group.
To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group.
To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.

开始日期2016-12-01

申办/合作机构

Sanofi Pasteur

100 项与 CYD Dengue Vaccine (sanofi) 相关的临床结果

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100 项与 CYD Dengue Vaccine (sanofi) 相关的转化医学

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100 项与 CYD Dengue Vaccine (sanofi) 相关的专利（医药）

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180

项与 CYD Dengue Vaccine (sanofi) 相关的文献（医药）

2024-04-15·Chemical and Pharmaceutical Bulletin

Sustained Release Formulation of Hydroxypropyl-β-cyclodextrin Eye Drops Using Xanthan Gum

Article

作者: Hirotsu, Tatsunori ; Goto, Taito ; Motoyama, Keiichi ; Higashi, Taishi ; Ikeda, Hanako Ohashi ; Onodera, Risako

Bietti's crystalline dystrophy (BCD) is an autosomal recessive chorioretinal degeneration caused by mutations in the CYP4V2 gene. It is characterized by cholesterol accumulation and crystal-like deposits in the retinas. Hydroxypropyl-β-cyclodextrin (HP-β-CyD) exerts therapeutic effects against BCD by reducing lysosomal dysfunction and inhibiting cytotoxicity in induced pluripotent stem cell (iPSC)-RPE cells established from patient-derived iPS cells. However, the ocular retention of HP-β-CyD is low and needs to be improved. Therefore, this study used a viscous agent to develop a sustained-release ophthalmic formulation containing HP-β-CyD. Our results suggest that HP-β-CyD-containing xanthan gum has a considerably higher sustained release capacity than other viscous agents, such as methylcellulose and sodium alginate. In addition, the HP-β-CyD-containing xanthan gum exhibited pseudoplastic behavior. It was less cytotoxic to human retinal pigment epithelial cells compared with HP-β-CyD alone. Furthermore, the slow release of HP-β-CyD from xanthan gum caused a sustained decrease in free intracellular cholesterol. These results suggest that xanthan gum is a useful substrate for the sustained release formulation of HP-β-CyD, and that HP-β-CyD-containing xanthan gum has potential as an eye drop for BCD treatment.

2023-06-01·Biometrics2区 · 数学

Nonparametric Estimation of the Causal Effect of a Stochastic Threshold-Based Intervention

2区 · 数学

Article

作者: Gilbert, Peter B. ; van der Laan, Lars ; Zhang, Wenbo

AbstractIdentifying a biomarker or treatment-dose threshold that marks a specified level of risk is an important problem, especially in clinical trials. In view of this goal, we consider a covariate-adjusted threshold-based interventional estimand, which happens to equal the binary treatment–specific mean estimand from the causal inference literature obtained by dichotomizing the continuous biomarker or treatment as above or below a threshold. The unadjusted version of this estimand was considered in Donovan et al.. Expanding upon Stitelman et al., we show that this estimand, under conditions, identifies the expected outcome of a stochastic intervention that sets the treatment dose of all participants above the threshold. We propose a novel nonparametric efficient estimator for the covariate-adjusted threshold-response function for the case of informative outcome missingness, which utilizes machine learning and targeted minimum-loss estimation (TMLE). We prove the estimator is efficient and characterize its asymptotic distribution and robustness properties. Construction of simultaneous 95% confidence bands for the threshold-specific estimand across a set of thresholds is discussed. In the Supporting Information, we discuss how to adjust our estimator when the biomarker is missing at random, as occurs in clinical trials with biased sampling designs, using inverse probability weighting. Efficiency and bias reduction of the proposed estimator are assessed in simulations. The methods are employed to estimate neutralizing antibody thresholds for virologically confirmed dengue risk in the CYD14 and CYD15 dengue vaccine trials.

2023-05-19·Pharmaceutics

The Role of Cyclodextrin in the Construction of Nanoplatforms: From Structure, Function and Application Perspectives.

Review

作者: Chi, Xinjin ; Zeng, Ling ; Zheng, Xiaoming ; Liu, Xin ; Xing, Chengyuan ; Deng, Tian

Cyclodextrins (CyDs) in nano drug delivery systems have received much attention in pursuit of good compatibility, negligible toxicity, and improved pharmacokinetics of drugs. Their unique internal cavity has widened the application of CyDs in drug delivery based on its advantages. Besides this, the polyhydroxy structure has further extended the functions of CyDs by inter- and intramolecular interactions and chemical modification. Furthermore, the versatile functions of the complex contribute to alteration of the physicochemical characteristics of the drugs, significant therapeutic promise, a stimulus-responsive switch, a self-assembly capability, and fiber formation. This review attempts to list recent interesting strategies regarding CyDs and discusses their roles in nanoplatforms, and may act as a guideline for developing novel nanoplatforms. Future perspectives on the construction of CyD-based nanoplatforms are also discussed at the end of this review, which may provide possible direction for the construction of more rational and cost-effective delivery vehicles.

100 项与 CYD Dengue Vaccine (sanofi) 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
严重登革热	临床2期	新加坡	Sanofi Pasteur	2009-04-07
登革热	药物发现	美国	Sanofi Pasteur	2011-12-06
黄热病	药物发现	美国	Sanofi Pasteur	2011-12-06

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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


NCT01488890 (CTgov)	临床2期	黄热病 \| 登革热	390	4 virus (CYD Dengue Vaccine: Group 1)	構鏇壓艱觸簾衊艱獵築(夢鬱蓋憲壓壓鹹遞選餘) = 艱夢製蓋構壓積壓積願膚糧淵齋遞觸廠鏇膚鏇 (壓醖簾積窪夢壓製窪膚, 構鹹鏇鹹簾醖醖願鏇廠 ~ 糧選築糧醖構獵衊範衊) 更多	-	2019-06-14
				4 virus (CYD Dengue Vaccine: Group 2)	構鏇壓艱觸簾衊艱獵築(夢鬱蓋憲壓壓鹹遞選餘) = 簾網構淵簾鑰遞顧齋觸膚糧淵齋遞觸廠鏇膚鏇 (壓醖簾積窪夢壓製窪膚, 廠鏇餘襯製醖鹹鏇鹹壓 ~ 願願遞積觸鏇築衊夢艱) 更多
NCT01943825 (CTgov)	临床2期	严重登革热	90	CYD Dengue Vaccine (CYD Dengue Vaccine: Group 1)	選壓獵製網顧獵淵築築(壓鑰選壓襯遞艱襯衊遞) = 網艱網壓襯衊膚鬱窪遞遞遞壓選鹹憲積製窪窪 (願簾獵衊顧淵簾鹽齋範, 範壓顧餘窪願壓願簾選 ~ 鑰衊鏇糧觸築鹹構構網) 更多	-	2020-02-05
				CYD Dengue Vaccine (CYD Dengue Vaccine: Group 2)	選壓獵製網顧獵淵築築(壓鑰選壓襯遞艱襯衊遞) = 鏇艱鏇廠蓋窪餘齋獵衊遞遞壓選鹹憲積製窪窪 (願簾獵衊顧淵簾鹽齋範, 襯蓋齋簾鑰願鑰製壓積 ~ 壓蓋鏇鹹選淵衊蓋顧顧) 更多
NCT02993757 (CTgov)	临床3期	乳头状瘤病毒感染 \| 严重登革热	528	CYD Dengue Vaccine+Human Papillomavirus Quadrivalent [Types 6, 11, 16, (CYD Dengue Vaccine + Gardasil (Concomitant Administration))	繭簾範製構糧襯鬱廠遞(廠餘網艱膚窪鹽糧願蓋): GMT ratio = 0.982 (95% CI, 0.664 ~ 1.45); GMT ratio = 0.804 (95% CI, 0.626 ~ 1.03); GMT ratio = 0.815 (95% CI, 0.608 ~ 1.09); GMT ratio = 0.795 (95% CI, 0.603 ~ 1.05) 更多	-	2020-06-11
				CYD Dengue Vaccine+Human Papillomavirus Quadrivalent [Types 6, 11, 16, (CYD Dengue Vaccine + Gardasil (Sequential Administration))
NCT02992418 (CTgov)	临床3期	严重登革热	688	CYD Dengue Vaccine+Tdap Vaccine (CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration))	製範淵鹽淵夢簾鑰遞鏇(鑰廠鑰憲蓋壓餘構鏇衊): GMC ratio = 0.848 (95% CI, 0.721 ~ 0.997); GMC ratio = 1.02 (95% CI, 0.892 ~ 1.18); GMC ratio = 1.11 (95% CI, 0.836 ~ 1.46); GMC ratio = 1.05 (95% CI, 0.827 ~ 1.33) 更多	-	2020-08-27
				CYD Dengue Vaccine+Tdap Vaccine (CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration))
NCT02979535 (CTgov)	临床3期	乳头状瘤病毒感染 \| 严重登革热	480	CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Concomitant Administration))	選製遞製鏇獵夢壓製鏇(獵築鬱醖窪鬱範遞鹽衊): GMT ratio = 0.947 (95% CI, 0.773 ~ 1.16); GMT ratio = 0.986 (95% CI, 0.803 ~ 1.21) 更多	-	2020-03-09
				CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Sequential Administration))
NCT00880893 (CTgov)	临床2期	严重登革热	1,198	CYD Dengue vaccine (CYD Dengue Vaccine Group)	(範鹹鑰觸選蓋廠鏇壓積) = 願範築鹹蓋齋淵遞簾壓鬱繭餘遞鹽襯淵廠廠製 (構餘積選願齋鹹艱膚蓋, 鹹糧願選夢網繭窪糧壓 ~ 觸網願衊廠膚範蓋積簾) 更多	-	2019-07-29
				NaCl + influenza virus or hepatitis A vaccine (Placebo Group)	(範鹹鑰觸選蓋廠鏇壓積) = 鑰繭艱觸膚糧選齋選願鬱繭餘遞鹽襯淵廠廠製 (構餘積選願齋鹹艱膚蓋, 壓鏇廠顧鹽繭襯鏇艱鏇 ~ 繭鹹餘鹹觸鬱鹽鹽製選) 更多