[Translation] Phase IIb clinical trial to evaluate the safety and tolerability of Mycobacterium tuberculosis antigen (D-EC) for skin testing in people aged 3 to 17 years and 66 to 75 years

主要研究目的：（1）评价皮肤试验用结核分枝杆菌抗原（D-EC）用于人体研究的安全性和耐受性；（2）评估 D-EC 临床使用剂量的不良反应发生率与 D-EC 的关联性。次要研究目的：（1）评价 D-EC 与 TB-PPD、IGRA 三种检测试剂在 66 周岁至 75 周岁人群胸部影像学检查正常受试者、肺结核患者中的关联性；（2）评价 D-EC 与 IGRA 两种检测试剂在 3 周岁至 17 周岁人群健康受试者、呼吸道疾病含结核病患者中的关联性；

[Translation]

Primary study objectives: (1) To evaluate the safety and tolerability of skin test Mycobacterium tuberculosis antigen (D-EC) in human studies; (2) To evaluate the correlation between the incidence of adverse reactions to the clinical dose of D-EC and D-EC. Secondary study objectives: (1) To evaluate the correlation between D-EC and three test reagents, TB-PPD and IGRA, in subjects with normal chest imaging and pulmonary tuberculosis aged 66 to 75 years; (2) To evaluate the correlation between D-EC and two test reagents, IGRA, in healthy subjects aged 3 to 17 years and patients with respiratory diseases including tuberculosis;

Start Date-

Sponsor / Collaborator

Kangweizhonghe (Zhongshan) Biopharmaceutical Co., Ltd.

[+1]

CTR20230091 / Active, not recruitingPhase 2

随机、盲法、同类制品对照探索重组结核杆菌融合蛋白（D-EC）在18～65周岁人群中皮试应用剂量的Ⅱ期临床试验

[Translation] A randomized, blinded, and similar product-controlled phase II clinical trial to explore the skin test application dose of recombinant Mycobacterium tuberculosis fusion protein (D-EC) in people aged 18 to 65 years old

（1）初步确定D-EC的阳性判定标准，为III期临床研究最终阳性判断标准确定提供依据；（2）确定III期临床使用剂量；（3）评估D-EC临床使用的安全性与剂量，及不良反应发生率与D-EC的关联性。

[Translation]

(1) Preliminarily determine the positive judgment criteria for D-EC to provide a basis for determining the final positive judgment criteria for Phase III clinical studies; (2) Determine the dose used in Phase III clinical studies; (3) Evaluate the safety and dose of D-EC in clinical use, and the correlation between the incidence of adverse reactions and D-EC.

Start Date31 Jan 2023

Sponsor / Collaborator

Kangweizhonghe (Zhongshan) Biopharmaceutical Co., Ltd.

[+1]

CTR20222098 / Active, not recruitingPhase 1

评价重组结核杆菌融合蛋白（D-EC）皮试后的安全性和耐受性I期临床研究

[Translation] Phase I clinical study to evaluate the safety and tolerability of recombinant tuberculosis fusion protein (D-EC) after skin test

试验目的是评价重组结核杆菌融合蛋白（D-EC）用于人体研究的安全性和耐受性

[Translation]

The purpose of the trial is to evaluate the safety and tolerability of recombinant Mycobacterium tuberculosis fusion protein (D-EC) for human studies

Start Date01 Sep 2022

Sponsor / Collaborator

Kangweizhonghe (Zhongshan) Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(D-EC)

100 Translational Medicine associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(D-EC)

100 Patents (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(D-EC)

Literatures (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(D-EC)

01 Apr 2010·Cancer Biotherapy and RadiopharmaceuticalsQ4 · MEDICINE

Vaccination with B16 Tumor Cell Lysate Plus RecombinantMycobacterium tuberculosisHsp70 Induces Antimelanoma Effect in Mice

Q4 · MEDICINE

Article

Author: Chen, Yajing ; Li, He ; Sun, Luguo ; Wan, Min ; Wei, Hongfei ; Yu, Yongli ; Wang, Li ; Zhang, Peiyin ; Wang, Ying ; Wang, Liying ; Cao, Zhao ; Dong, Bohan ; Wang, Hua

Tumor cell lysate (TCL) has an advantage of containing an extensive repertoire of tumor antigens but requires proper adjuvants to enhance its immunogenicity when used as an efficient tumor vaccine. Mycobacterium tuberculosis-derived heat shock protein 70 (TBHsp70) has been shown to assist crosspresentation of exogenously applied tumor antigens and activate innate immunity against tumor cells. In this study, TBHsp70-B16TCL, a preparation generated by mixing recombinant TBHsp70 and TCL of B16 melanoma cells directly, was tested for its immunogenicity as a tumor vaccine. The TBHsp70-B16TCL induced a significant inhibition of the growth and metastasis of B16 melanoma in mice and prolonged the survival of B16 melanoma-bearing mice. The inhibition was correlated with the specific immune responses induced by TBHsp70-B16TCL. The data suggest that recombinant TBHsp70-adjuvanted TCL might be developed into effective tumor vaccines for melanomas and possibly for other tumors.

01 Apr 2002·Poultry ScienceQ2 · AGRICULTURAL & FORESTRY SCIENCE

Active immunization of broiler breeder hens with a recombinant chicken inhibin fusion protein enhances egg lay

Q2 · AGRICULTURAL & FORESTRY SCIENCE

ArticleOA

Author: G. G. Cadd ; W. C. Fioretti ; D. G. Satterlee

We have demonstrated that inoculation of female Coturnix with an inhibin-based immunogen (MBP-cINA521) accelerated puberty and enhanced hen-day egg production (HDEP). Herein, MBP-cINA521, a fusion protein, which consists of the bacterial maltose binding protein (MBP) and a fragment of the infinity-subunit of chicken inhibin (cINA521), was tested for its ability to enhance production performance in broiler breeders. Pullets (Arbor Acres Classic Females; n = 60 birds/treatment group) were given (subcutaneously) 0, 1, 3, or 5 mg of MBP-cINA521 in Freund's complete adjuvant at 20 wk and 4 d of age. Booster immunizations (one-half of the primary dosages) were given at 23 wk of age. The vehicle for controls (CON; no booster) and MBP-cINA521-boosted birds was Freund's incomplete adjuvant. Blood samples were obtained at the end of the trial to assess immunological response to the antigen with a titer ELISA. The onset of puberty was assessed by calculation of the average ages at first lay (FIRST) and at 50% egg production (FIFTY). Cumulative percentage HDEP was determined weekly throughout the laying period (40 wk). Egg weight (EWT) and specific gravity (SG) assessments were made periodically during the trial. Body weight gain (BWG) and mortality (MORT) data were also collected. Significant injection treatment differences (P < 0.01) in inhibin antibody titers were detected according to the following order: low dose = intermediate dose > high dose > CON. A dose of MBP-cINA521 capable of accelerating puberty and increasing overall egg lay was identified. FIRST and FIFTY responses were decreased (P < 0.05) in birds given the intermediate dose (3.0 mg) of MBP-cINA521 when compared to the CON. FIFTY responses were also lower (P < 0.05) than CON responses in those birds given the highest dose (5.0 mg) of the inhibin antigen. Cumulative HDEP was also higher (P < 0.05), beginning at 3 wk of lay and weekly thereafter (P < 0.05, for the remaining 40 wk), in birds given the intermediate immunogen dosage when compared to the CON. By Week 40, an average increase of 9.5% HDEP was realized in birds given 3.0 mg of MBP-cINA521. MORT rates were similar in the CON and in the two lowest MBP-cINA521 treatment groups but were higher (P < 0.05) in those birds given 5.0 mg of the antigen. EWT, SG, and BWG measurements were unaffected by treatment with the inhibin vaccine. In agreement with our findings in quail, immunoneutralization of inhibin enhanced production performance in breeder hens.

01 Jun 1998·Poultry ScienceQ2 · AGRICULTURAL & FORESTRY SCIENCE

Active immunization of Japanese quail hens with a recombinant chicken inhibin fusion protein enhances production performance

Q2 · AGRICULTURAL & FORESTRY SCIENCE

ArticleOA

Author: JD Moreau ; WC Fioretti ; DG Satterlee ; GG Cadd ; KG Kousoulas ; JJ Rejman

The effects of active immunization against inhibin on production performance in female Japanese quail (Coturnix coturnix japonica) were assessed in two separate trials using an MBP-cINA521 fusion protein as an immunogen. The fusion protein, MBP-cINA521, consisted of the bacterial maltose binding protein (MBP) and a truncated form of the mature alpha-subunit of chicken inhibin (cINA521). MBP-cINA1521 was constructed by: 1) excising a 521-bp PstI fragment from a chicken inhibin alpha-subunit cDNA (cINA6; gift of P. A. Johnson), 2) cloning this fragment, which encodes all but the first 11 amino acid residues of the mature alpha-subunit, into the pMal-c2 vector of the MBP fusion expression system, and 3) expressing the fusion protein (MBP-cINA521) from the Escherichia coli and purifying it using affinity chromatography. In each trial, quail were randomly and equally assigned to one of two injection treatments as follows: 1) MBP-cINA521 in Freund's adjuvant, or 2) Freund's adjuvant (vehicular controls; CON). All immunizations were given subcutaneously and Freund's complete and incomplete adjuvant were used for primary and booster injections, respectively. In Trial 1, birds were given a primary challenge of 0.2 mg MBP-cINA521 per bird at 25 d of age, followed by booster immunizations (0.1 mg MBP-cINA521 per bird) at 33, 40, 47, 54 and 61 d of age and every 35 d thereafter. The CON birds received vehicular immunizations at the same time intervals. In Trial 2, birds treated with MBP-cINA521 received a primary challenge of 0.2 mg MBP-cINA521 per bird at 26 d of age, followed by booster immunizations (0.1 mg MBP-cINA521 per bird) using the same schedule as that used in Trial 1, with the exception that no boosters were given after 61 d of age. The CON birds received vehicular immunizations at the same time intervals. Collection of production performance data was initiated coincident with the laying of the first egg in each trial (i.e., beginning at 41 and 44 d of age for Trials 1 and 2, respectively) and continued for 30 1-wk periods of lay. Combined data from Trials 1 and 2 indicated that the mean +/- SE age at first egg lay was markedly decreased (P < 0.005) in MBP-cINA521-treated quail (53.4 +/- 0.9 d of age) when compared to the CON (57.6 +/- 1.3 d of age). Likewise, the mean +/- SE age at 50% egg production was reduced (P < 0.03) in quail immunized against inhibin (65.4 +/- 2.1 d of age) when compared to the CON (77.6 +/- 4.7 d of age). Total hen-day egg production was also higher (P < 0.05, Trial 1; P < 0.01, Trial 2) in MBP-cINA521-treated quail (88.7 +/- 1.4%, Trial 1; 90.1 +/- 1.2%, Trial 2) than in the CON birds (81.9 +/- 2.9%, Trial 1; 73.6 +/- 6.5%, Trial 2). Collectively, these findings provide evidence that inhibin immunoneutralization accelerated puberty and enhanced hen-day egg production during a 30-wk period of egg lay in Japanese quail.

100 Deals associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(D-EC)

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Indication	Highest Phase	Country/Location	Organization	Date
Tuberculosis	Phase 2	CN	Kangweizhonghe (Zhongshan) Biopharmaceutical Co., Ltd.	31 Jan 2023

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