Delving into the Latest Updates on Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy) with Synapse

Overview

Basic Info

Drug Type

Other diagnostic agent, Fusion protein

Synonyms

宜卡

Target-

Action-

Mechanism

tuberculosis skin test

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

TuberculosisPulmonary Tuberculosis

Inactive Indication

Tuberculosis, extrapulmonary

Originator Organization

Anhui Longcom Biologic Pharmacy Co., Ltd.

Active Organization

Anhui Longcom Biologic Pharmacy Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Apr 2020),

Tuberculosis

Regulation-

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主要目的：（1）在65周岁及以上结核病患者（确诊病例、临床诊断病例）中考察EC的灵敏度；（2）在65周岁及以上无其他肺部疾患的社区健康人群中考察EC的特异度；（3）在65周岁及以上人群中评价EC使用的安全性。次要目的：（1）在研究人群中考察EC在不同判定时间（24 h、48 h、72 h）的诊断结果、分析诊断时间与诊断标准的交互作用、评价诊断标准（红晕和/或硬结）的合理性，优化本品皮试结果的判断时间以及阳性判断标准；（2）在65周岁及以上非结核性有其他肺部疾患的社区人群中考察EC的特异度；（3）在65周岁及以上无其他肺部疾患的社区健康人群中评价EC与TB-PPD结果的关联性。

[Translation]

Main objectives: (1) To investigate the sensitivity of EC in patients with tuberculosis aged 65 years and above (confirmed cases, clinically diagnosed cases); (2) To investigate the specificity of EC in healthy community population aged 65 years and above without other lung diseases; (3) To evaluate the safety of EC use in people aged 65 years and above. Secondary objectives: (1) To investigate the diagnostic results of EC at different judgment times (24 h, 48 h, 72 h) in the study population, analyze the interaction between the diagnosis time and the diagnostic criteria, evaluate the rationality of the diagnostic criteria (red halo and/or nodule), and optimize the judgment time and positive judgment criteria of the skin test results of this product; (2) To investigate the specificity of EC in community population aged 65 years and above with other non-tuberculous lung diseases; (3) To evaluate the correlation between EC and TB-PPD results in healthy community population aged 65 years and above without other lung diseases.

Start Date03 Aug 2023

Sponsor / Collaborator

Anhui Longcom Biologic Pharmacy Co., Ltd.

ChiCTR2300070447

/ SuspendedPhase 4IIT

To conduct a phase IV clinical trial of recombinant Mycobacterium tuberculosis fusion protein (EC) in community population aged 6 months and over

Start Date19 Apr 2023

Sponsor / Collaborator-

100 Clinical Results associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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100 Translational Medicine associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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100 Patents (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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10

Literatures (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

01 Mar 2022·Clinical Infectious DiseasesQ1 · MEDICINE

Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials

Q1 · MEDICINE

Article

Author: Zhang, Rongping ; Zhou, Rongguang ; Ding, Xiaoyan ; Lu, Shuihua ; Pu, Jiang ; Du, Weixin ; Tao, Lifeng ; Xu, Miao ; Mei, Zaoxian ; Lu, Jinbiao ; Martinez, Leonardo ; Liu, Qiao ; Liu, Min ; Li, Feng ; Xi, Xiuhong ; Chen, Baowen ; Lu, Wei ; Wu, Qi ; Li, Tao ; Yuan, Baodong ; Li, Jingxin ; Du, Ronghui ; Zhu, Fengcai ; Wang, Guozhi

AbstractBackgroundDiagnostics to identify tuberculosis infection are limited. We aimed to assess the diagnostic accuracy and safety of ESAT6-CFP10 (EC) skin test for tuberculosis infection in Chinese adults.MethodsWe conducted 2 randomized, parallel-group clinical trials in healthy participants and tuberculosis patients. All participants were tested with the T-SPOT.TB test, then received an EC skin test and tuberculin skin test (TST). The diameter of skin indurations and/or redness at injection sites were measured at different time periods. A bacillus Calmette Guerin (BCG) model was established to assess the diagnosis of tuberculosis infection using an EC skin test.ResultsIn total, 777 healthy participants and 96 tuberculosis patients were allocated to receive EC skin test at 1.0 μg/0.1 mL or 0.5 μg/0.1 mL. The area under the curve was 0.95 (95% confidence interval [CI], .91–.97) for the EC skin test at 1.0 μg/0.1 mL at 24–72 hours. Compared with the T-SPOT.TB test, the EC skin test demonstrated similar sensitivity (87.5, 95% CI, 77.8–97.2 vs 86.5, 95% CI, 79.5–93.4) and specificity (98.9, 95% CI, 96.0–99.9 vs 96.1, 95% CI, 93.5–97.8). Among BCG vaccinated participants, the EC skin test had high consistency with the T-SPOT.TB test (96.3, 95% CI, 92.0–100.0). No serious adverse events related to the EC skin test were observed.ConclusionsThe EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0 μg/0.1 mL, comparable to the T-SPOT.TB test. The diagnostic accuracy of the EC skin test was not impacted by BCG vaccination.Clinical Trials RegistrationNCT02389322 and NCT02336542.

01 Jul 2019·VaccineQ3 · MEDICINE

Ag85b/ESAT6-CFP10 adjuvanted with aluminum/poly-IC effectively protects guinea pigs from latent mycobacterium tuberculosis infection

Q3 · MEDICINE

Article

Author: Du, Weixin ; Su, Cheng ; Wang, Guozhi ; Xu, Miao ; Yang, Lei ; Chen, Baowen ; Li, Xuguang ; Wang, Chunhua ; Wang, Junzhi ; Lu, Jinbiao ; Shen, Xiaobin

The high global burden of tuberculosis (TB) underscores the urgent need for an effective TB vaccine since the only licensed Bacillus Calmette-Guérin (BCG) vaccine is ineffective in preventing adult pulmonary TB and affords no protection against latent TB infection (LTBI). Herein we investigated the potential of Mycobacterium tuberculosis (Mtb) antigen proteins AEC comprised of Ag85b and ESAT6-CFP10 proteins in conjunction with aluminum (Al) and polyriboinosinic-polyribocytidylic acid (poly-IC) as a novel subunit vaccine against TB. The immunogenicity and protection induced by the adjuvanted vaccine were evaluated in two animal models. Mice vaccinated with AEC/Al/poly-IC exhibited significant antigen-specific humoral immune responses and cell-mediated immunity as determined by immunoassay and multicolor flow cytometric assay, and the protective effect of the vaccine was demonstrated in a guinea pig model of latent Mtb infection. Compared to the control group, the mean pathological scores and bacterial loads in lungs and spleens of AEC/Al/poly-IC-immunized guinea pigs were significantly reduced. These data indicate that the AEC/Al/poly-IC is highly immunogenic in mice and can effectively protect guinea pigs against latent Mtb infection; it may represent a promising candidate vaccine for the control of latent TB.

01 Oct 2016·Clinical Microbiology and InfectionQ1 · MEDICINE

Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis: an open-label, randomized, two-centre phase 2a clinical trial

Q1 · MEDICINE

Article

Author: Lu, S ; Xu, M ; Pu, J ; Xi, X ; Gu, J ; Wang, G ; Li, F ; Fan, X ; Xiong, Y ; Wu, Q ; Xia, L ; Qin, C

We sought to assess the accuracy and safety of the ESAT6-CFP10 reagent in diagnosing tuberculosis (TB) disease. An open-label, randomized phase 2a trial was conducted in 56 healthy adults and 88 TB patients at one medical centre and one teaching hospital in China. All participants received 0.1, 0.5, 1 or 2 μg ESAT6-CFP10 in their right forearm. Moreover, 56 healthy volunteers and 56 patients were given tuberculin-purified protein derivative (TB-PPD) in their left forearm. The remaining 32 patients were administered placebo. The main outcome measure was induration diameter. An enzyme-linked immunospot (ELISPOT) assay was conducted before the skin test. The ESAT6-CFP10 test caused a higher positivity rate than placebo (81.2% (26/32) vs. 3.1% (1/32); p <0.001). The median maximum induration diameter after ESAT6-CFP10 injection was 17.0 (interquartile range (IQR), 14.0-21.7) mm, similar to that for TB-PPD (17.5 (IQR, 7.0-30.5) mm). The diagnostic accuracy of ESAT6-CFP10 was superior to that of TB-PPD (area under the receiver operating characteristic curve (AUC), 0.870 (95% confidence interval (CI), 0.796-0.944) vs. 0.686 (95% CI, 0.585-0.786); p <0.001). When analysed in all participants, ESAT6-CFP10 had comparable AUC values to the ELISPOT assay (0.849 (95% CI, 0.835-0.952) vs. 0.908 (95% CI, 0.852-0.965)). Local itching (12/144, 8.3%) and pain (26/144, 18.1%) were the main side effects of ESAT6-CFP10. No serious adverse events were reported. The ESAT6-CFP10 skin test appears to be a safe and promising tool; further testing will confirm its efficacy in identifying TB disease.

100 Deals associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Tuberculosis	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	01 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 3	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	17 Dec 2015
Tuberculosis, extrapulmonary	Preclinical	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	17 Dec 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02389322 \| NCT02336542 (Pubmed \| Clin Infect Dis)	Phase 2	Tuberculosis	-	ESAT6-CFP10 (EC skin test at 1.0μg/0.1ml)	(njexgzftic) = fguvktxroh xvlkgirlbf (usdjckaody, 77.8 - 97.2) View more	-	22 May 2021
NCT01999231 (CTgov)	Phase 1	Tuberculosis \| Pulmonary Tuberculosis \| Tuberculosis, extrapulmonary	32	ESAT6-CFP10 (1μg/ml ESAT6-CFP10)	xunmdmeohq(kgaahbzqoy) = cjknnysxnr msfahaimir (rmapdohpph, xkrfumxrlg - fcawknvkjv) View more	-	31 Mar 2015
NCT01999231 (CTgov)	Phase 1		32	ESAT6-CFP10 (5μg/ml ESAT6-CFP10)	xunmdmeohq(kgaahbzqoy) = wabvxfpcnq msfahaimir (rmapdohpph, voblezaqee - xvkzfpxidb) View more	-	31 Mar 2015

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