Sh28GST(Sh28GST) - 在研适应症：血吸虫病_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

Centre Hospitalier Universitaire de Lille

Institut National de la Santé et de la Recherche Médicale

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 9156692

关联

3

项与 Sh28GST 相关的临床试验

NCT02281916 / Completed临床2期IIT

Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

开始日期2014-03-01

申办/合作机构

Centre Hospitalier Universitaire de Lille

[+2]

NCT00870649 / Completed临床3期IIT

Efficacy and Safety Evaluation of the Therapeutic Vaccine Candidate Sh28GST in Association With Praziquantel (PZQ) for Prevention of Clinical and Parasitological Recurrences of S. Haematobium Infection in Children

Objectives:To reduce the risk of S. haematobium pathology recurrences during the three years following vaccine administration and to control the safety of this therapeutic strategy in children exposed to urinary schistosomiasis.
Methodology : Phase III trial, self-contained, randomized, double blind, in two parallel groups receiving 3 injections at D0, W4, W8 and a boost at W52, one group receiving "Bilhvax", the other one placebo, in S. haematobium infected children pretreated by two doses of PZQ (at W9 and W8) Patient included : Infected school children, 6 to 9 years of age.
Primary objective : To demonstrate a significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group in the 3 years period following the first administration (between D0 and W152).
Secondary objective : safety
Duration : February 2009 to March 2012

开始日期2009-02-01

申办/合作机构

Institut National de la Santé et de la Recherche Médicale

NCT01512277 / Completed临床1期IIT

Phase 1 Study Evaluating Safety and Immunological Criteria of Efficacy of the Recombinant Vaccine Candidate Bilhvax Against Schistosomiasis

The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.

开始日期1998-09-01

申办/合作机构

Centre Hospitalier Universitaire de Lille

[+1]

100 项与 Sh28GST 相关的临床结果

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100 项与 Sh28GST 相关的转化医学

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100 项与 Sh28GST 相关的专利（医药）

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9

项与 Sh28GST 相关的文献（医药）

2017-11-01·International Journal of Pharmaceutics2区 · 医学

Preparation and investigation of P28GST-loaded PLGA microparticles for immunomodulation of experimental colitis

2区 · 医学

Article

作者: Thi, T H Hoang ; Capron, M ; Dendooven, A ; Karrout, Y ; Driss, V ; Delbeke, M ; Priemel, P A ; Siepmann, J ; Flament, M P

The aim of this work was to prepare and characterize (in vitro and in vivo) PLGA-based microparticles loaded with an enzymatic protein derived from the helminth parasite Schistosoma haematobium: glutathione S-transferase P28GST (P28GST). This protein is not only a promising candidate vaccine against schistosomiasis, it also exhibits interesting immunomodulating effects, which can be helpful for the regulation of inflammatory diseases. Helminths express a regulatory role on intestinal inflammation, and immunization by P28GST has recently been shown to be as efficient as infection to reduce inflammation in a murine colitis model. As an alternative to the combination with a classical adjuvant, long acting P28GST microparticles were prepared in order to induce colitis prevention. PLGA was used as biodegradable and biocompatible matrix former, and a W/O/W emulsion/solvent extraction technique applied to prepare different types of microparticles. The effects of key formulation and processing parameters (e.g., the polymer molecular weight, drug loading, W/O/W phase volumes and stirring rates of the primary/secondary emulsions) on the systems' performance were studied. Microparticles providing about constant P28GST release during several weeks were selected and their effects in an experimental model of colitis evaluated. Mice received P28GST-loaded or P28GST-free PLGA microparticles (s.c.) on Day 0, and optionally also on Days 14 and 28. Colitis was induced on Day 35, the animals were sacrificed on Day 37. Interestingly, the Wallace score (being a measure of the severity of the inflammation) was significantly lower in mice treated with P28GST microparticles compared to placebo after 1 or 3 injections. As immunogenicity markers, increased anti-P28GST IgG levels were detected after three P28GST PLGA microparticle injections, but not in the control groups. Thus, the proposed microparticles offer an interesting potential for the preventive treatment of experimental colitis, while the underlying mechanism of action is still to be investigated.

2016-06-01·Vaccine3区 · 医学

Advancing a vaccine to prevent human schistosomiasis

3区 · 医学

Review

作者: Ulrich Strych ; Peter J. Hotez ; Tara Hayward ; Coreen M. Beaumier ; Maureen Merrifield ; Maria Elena Bottazzi ; Portia Gillespie

Several candidate human schistosomiasis vaccines are in different stages of preclinical and clinical development. The major targets are Schistosoma haematobium (urogenitial schistosomiasis) and Schistosoma mansoni (intestinal schistosomiasis) that account for 99% of the world's 252 million cases, with 90% of these cases in Africa. Two recombinant S. mansoni vaccines - Sm-TSP-2 and Sm-14 are in Phase 1 trials, while Smp80 (calpain) is undergoing testing in non-human primates. Sh28GST, also known as Bilhvax is in advanced clinical development for S. haematobium infection. The possibility remains that some of these vaccines may cross-react to target both schistosome species. These vaccines were selected on the basis of their protective immunity in preclinical challenge models, through human immune-epidemiological studies or both. They are being advanced through a combination of academic research institutions, non-profit vaccine product development partnerships, biotechnology companies, and developing country vaccine manufacturers. In addition, new schistosome candidate vaccines are being identified through bioinformatics, OMICs approaches, and moderate throughput screening, although the full potential of reverse vaccinology for schistosomiasis has not yet been realized. The target product profiles of these vaccines vary but many focus on vaccinating children, in some cases following mass treatment with praziquantel, also known as vaccine-linked chemotherapy. Several regulatory pathways have been proposed, some of which rely on World Health Organization prequalification.

2003-05-01·Acta Tropica3区 · 医学

Progress towards a vaccine for schistosomiasis

3区 · 医学

Review

作者: Pearce, Edward J

Schistosomiasis continues to be a significant health problem, especially in Africa. While the recent World Health Assembly resolution to apply mass drug treatment of school age children in endemic areas is a very promising development, a preferable long-term solution would be provided by a protective vaccine. Encouragingly, one vaccine, Bilhvax, is in phase II trials. However, there is a danger that momentum towards the goal of developing a vaccine against schistosomiasis is dissipating. This article reviews the current situation in this important area of schistosomiasis research.

100 项与 Sh28GST 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
血吸虫病	临床3期	-	Atos SE	-
克罗恩病	临床2期	法国	Centre Hospitalier Universitaire de Lille	2014-03-01
埃及血吸虫病	临床2期	塞内加尔	Institut National de la Santé et de la Recherche Médicale	2009-02-01

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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


NCT00870649 (Bilhvax3, Pubmed) 人工标引	临床3期	埃及血吸虫病	250	rSh28GST	(艱窪構鹹鏇淵衊壓鹽淵) = 網膚壓網選願鏇網繭齋範糧壓觸壓窪艱遞鹹遞 (築餘鹽鏇憲鑰憲餘糧餘 )	不佳	2018-12-07
				Placebo	(艱窪構鹹鏇淵衊壓鹽淵) = 壓夢醖糧鹹製構觸襯鹹範糧壓觸壓窪艱遞鹹遞 (築餘鹽鏇憲鑰憲餘糧餘 )