Mycobacterium vaccae vaccine(Immune Network Ltd.)(Mycobacterium vaccae vaccine(Immune Network Ltd.))

概要

基本信息

药物类型

治疗性疫苗

别名

Heat-inactivated M. vaccae pill、Mycobacterium vaccae vaccine、V-7 Immunitor

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

肺结核

非在研适应症-

原研机构

Immune Network Ltd.

在研机构

Immune Network Ltd.

Immunitor, Inc.

非在研机构-

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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关联

2

项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的临床试验

NCT01977768

/ Completed临床3期

Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)

The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.

开始日期2014-03-01

申办/合作机构

Immunitor, Inc.

[+3]

NCT01380119

/ Completed临床2期IIT

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

开始日期2011-08-01

申办/合作机构

Immunitor USA Inc.

[+1]

100 项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的临床结果

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100 项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的转化医学

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100 项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的专利（医药）

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55

项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的文献（医药）

2024-09-01·Molecular Immunology

Mycobacterium vaccae attenuates airway inflammation by inhibiting autophagy and activating PI3K/Akt signaling pathway in OVA-induced allergic airway inflammation mouse model

Article

作者: Wang, Fan ; Xiao, Huan ; Li, Chao-Qian ; Chen, Hong-Liu ; Xu, Mei-Li ; Tang, An-Zhou

PURPOSEThe etiology of asthma remains elusive, with no known cure. Based on accumulating evidence, autophagy, a self-degradation process that maintains cellular metabolism and homeostasis, participates in the development of asthma. Mycobacterium vaccae vaccine (M. vaccae), an immunomodulatory agent, has previously been shown to effectively alleviate airway inflammation and airway remodeling. However, its therapeutic effect on asthma via the regulation of autophagy remains unknown. Therefore, this study aimed to investigate the impact of M. vaccae in attenuating asthma airway inflammation via autophagy-mediated pathways.METHODSBalb/c mice were used to generate an ovalbumin (OVA)-immunized allergic airway model and were subsequently administered either M. vaccae or M. vaccae + rapamycin (an autophagy activator) prior to each challenge. Next, airway inflammation, mucus secretion, and airway remodeling in mouse lung tissue were assessed via histological analyses. Lastly, the expression level of autophagy proteins LC3B, Beclin1, p62, and autolysosome was determined both in vivo and in vitro, along with the expression level of p-PI3K, PI3K, p-Akt, and Akt in mouse lung tissue.RESULTSThe findings indicated that aerosol inhalation of M. vaccae in an asthma mouse model has the potential to decrease eosinophil counts, alleviate airway inflammation, mucus secretion, and airway remodeling through the inhibition of autophagy. Likewise, M. vaccae could reduce the levels of OVA-specific lgE, IL-5, IL-13, and TNF-α in asthma mouse models by inhibiting autophagy. Furthermore, this study revealed that M. vaccae also suppressed autophagy in IL-13-stimulated BEAS-2B cells. Moreover, M. vaccae may activate the PI3K/Akt signaling pathway in the lung tissue of asthmatic mice.CONCLUSIONIn summary, the present study suggests that M. vaccae may contribute to alleviating airway inflammation and remodeling in allergic asthma by potentially modulating autophagy and the PI3K/Akt signaling pathway. These discoveries offer a promising avenue for the development of therapeutic interventions targeting allergic airway inflammation.

2024-04-01·Immunology

Mycobacterium vaccae alleviates allergic airway inflammation and airway hyper‐responsiveness in asthmatic mice by altering intestinal microbiota

Article

作者: Li, Chao-Qian ; Xu, Mei-Li ; Xiao, Huan ; Wei, Xiao-Shua ; Chen, Hong-Liu ; Tang, An-Zhou ; Pang, Guo-Dong ; Fang, Li-Ting

AbstractHost immunity can influence the composition of the gut microbiota and consequently affect disease progression. Previously, we reported that a Mycobacterium vaccae vaccine could ameliorate allergic inflammation in asthmatic mice by regulating inflammatory immune processes. Here, we investigated the anti‐inflammatory effects of M. vaccae on allergic asthma via gut microbiota modulation. An ovalbumin (OVA)‐induced asthmatic murine model was established and treated with M. vaccae. Gut microbiota profiles were determined in 18 BALB/c mice using 16S rDNA gene sequencing and metabolomic profiling was performed using liquid chromatography quadrupole time‐of‐flight mass spectrometry. Mycobacterium vaccae alleviated airway hyper‐reactivity and inflammatory infiltration in mice with OVA‐induced allergic asthma. The microbiota of asthmatic mice is disrupted and that this can be reversed with M. vaccae. Additionally, a total of 24 differential metabolites were screened, and the abundance of PI(14:1(9Z)/18:0), a glycerophospholipid, was found to be correlated with macrophage numbers (r = 0.52, p = 0.039). These metabolites may affect chemokine (such as macrophage chemoattractant protein‐1) concentrations in the serum, and ultimately affect pulmonary macrophage recruitment. Our data demonstrated that M. vaccae might alleviate airway inflammation and hyper‐responsiveness in asthmatic mice by reversing imbalances in gut microbiota. These novel mechanistic insights are expected to pave the way for novel asthma therapeutic strategies.

2023-08-01·Obesity

Effect of synbiotics on weight loss and metabolic health in adults with overweight and obesity: A randomized controlled trial

Article

作者: Chandrasekaran, Kartik ; Srivastava, Shalini ; Lyon, John ; Connell, Mary

AbstractObjectiveThe study aimed to investigate the effect of synbiotics on body composition and metabolic health in individuals with excessive body weight.MethodsThe 12‐week randomized, double‐blind, placebo‐controlled clinical trial had individuals aged 30 to 60 years with BMI of 25 to 34.9 kg/m2. In total, 172 participants were randomly allocated to either synbiotic V5 or V7 groups or the placebo group. The primary outcome was change in BMI and body fat percentage. Secondary outcomes were changes in weight, other metabolic health and inflammatory markers, gastrointestinal quality of life, and eating behaviors.ResultsThe V5 and V7 groups had a significant reduction in BMI (p < 0.0001) from baseline to the end of the study, as opposed to the nonsignificant change in the placebo group (p = 0.0711). This reduction in the V5 and V7 groups was statistically significant when compared individually with the change in the placebo group (p < 0.0001). This corresponded well with the decrease in body weight with V5 and V7 (p < 0.0001). In addition, compared with placebo, the increase in high‐density lipoprotein was statistically significant in the V5 (p < 0.0001) and V7 groups (p = 0.0205). A similar trend was observed in the high‐sensitivity C‐reactive protein levels, with a statistically significant decrease in the V5 (p < 0.0001) and V7 (0.0005) groups.ConclusionsThe study demonstrates that synbiotic V5 and V7 were effective in reducing body weight in individuals with lifestyle modification.

100 项与 Mycobacterium vaccae vaccine(Immune Network Ltd.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肺结核	临床3期	-	Immunitor, Inc.	-
肺结核	临床3期	-	Immune Network Ltd.	-
结核	临床前	乌克兰	Immunitor, Inc.	2014-03-01
结核	临床前	蒙古	Immunitor, Inc.	2014-03-01

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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


NCT01977768 (imm03, Pubmed) 人工标引	临床3期	结核	152	V7	(願鑰膚糧淵鹽憲製網鹹) = 窪窪夢廠獵壓憲齋構齋築鬱願膚積夢顧獵蓋繭 (範遞鬱齋淵鬱築鹽顧積 ) 更多	积极	2019-12-12
				Placebo	(願鑰膚糧淵鹽憲製網鹹) = 簾網夢壓顧蓋範衊鬱壓築鬱願膚積夢顧獵蓋繭 (範遞鬱齋淵鬱築鹽顧積 ) 更多
NCT01380119 (Pubmed \| Immunotherapy)	临床2期	结核	41	heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7) (V7 (heat-killed Mycobacterium vaccae))	構壓鏇廠衊淵憲鹹網壓(淵糧網簾齋憲範齋鹹製) = 鏇製窪遞構積鏇積餘齋選鑰觸願鏇憲糧襯憲衊 (選願齋鹽獵夢簾選觸鏇 )	积极	2013-10-01
				Placebo	構壓鏇廠衊淵憲鹹網壓(淵糧網簾齋憲範齋鹹製) = 簾鏇糧積膚夢築蓋願鏇選鑰觸願鏇憲糧襯憲衊 (選願齋鹽獵夢簾選觸鏇 )
NCT01380119 (Pubmed \| Hum Vaccin Immunother)	临床2期	结核	43	heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7) (V7 (heat-killed Mycobacterium vaccae))	(憲醖憲窪衊鏇淵艱醖構) = 願顧鏇壓選蓋選齋蓋艱廠憲築艱鏇網範膚鑰淵 (構願積蓋廠淵鬱築餘淵 )	-	2013-09-01