Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

NCT ID: NCT05899179

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2025-10-31

Brief Summary

A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.

Detailed Description

A multicenter, randomized, blind, controlled trial design was adopted in this study. Subjects were enrolled in this clinical study after being qualified by physical examination, vital signs detection (body temperature, blood pressure, pulse and respiration), chest imaging (DR/CT) examination, mycobacterium tuberculosis etiology examination, HIV antibody detection, fasting blood glucose detection, etc.

A total of 240 TB patients, 120 non-tuberculous community people with other lung diseases, and 420 healthy community people without other lung diseases were selected for inclusion in this study. Blood samples were collected for specific gamma-interferon (T-SPOT) detection, and then EC and TB-PPD in the same double arm skin test were used to observe and record the results.

The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.

Vital signs (body temperature, blood pressure, pulse and respiration) were measured 30min and 24h after skin test, and body temperature was measured 48h and 72h after skin test. The skin reaction at the injection site was observed at 0min, 24h, 48h and 72h after skin test.

Conditions

Latent Tuberculosis Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Left arm injection EC group

The Recombinant Mycobacterium tuberculosis fusion protein(EC) was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.

Group Type: EXPERIMENTAL

Recombinant Mycobacterium Tuberculosis Fusion Protein

Intervention Type: BIOLOGICAL

Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.

1. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.

Purified Protein Derivative of Tuberculin

Intervention Type: BIOLOGICAL

Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle.

Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method.

Right arm injection EC group

The Recombinant Mycobacterium tuberculosis fusion protein(EC) was injected intradermally into the volar side of the right forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the left forearm.

Group Type: ACTIVE_COMPARATOR

Recombinant Mycobacterium Tuberculosis Fusion Protein

Intervention Type: BIOLOGICAL

Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.

1. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.

Purified Protein Derivative of Tuberculin

Intervention Type: BIOLOGICAL

Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle.

Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method.

Interventions

Recombinant Mycobacterium Tuberculosis Fusion Protein

Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.

1. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.

Intervention Type: BIOLOGICAL

Purified Protein Derivative of Tuberculin

Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle.

Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method.

Intervention Type: BIOLOGICAL

Other Intervention Names

EC; TB-PPD

Eligibility Criteria

Inclusion Criteria

• 65 years old and above (≥ 65 years old), male or female, the subjects themselves voluntarily participate in this study, sign the informed consent form, and can understand and comply with the requirements of the trial protocol to participate in follow-up.
• Normal underarm body temperature (< 37.3 °C);
• Tuberculosis patients: pulmonary tuberculosis patients and extrapulmonary tuberculosis patients diagnosed by researchers as confirmed cases of tuberculosis and clinically diagnosed cases. Refer to the "WS288-2017 Tuberculosis Diagnostic Criteria" to formulate the diagnostic criteria for pulmonary tuberculosis in this protocol, see Annex 1 for details; The diagnostic criteria for extrapulmonary tuberculosis were formulated with reference to the Technical Guidelines for Tuberculosis Prevention and Control in China (2021 edition of the Chinese Center for Disease Control and Prevention), as detailed in Annex 2.
• Non-tuberculous community population with other lung diseases: there is a clear lung disease, but the study physician can exclude pulmonary tuberculosis based on the patient's clinical manifestations, chest imaging and laboratory tests. Diagnostic criteria for their main types of nontuberculous other lung diseases can be found in Annex 3;
• Community healthy people without other lung diseases: those who have no history of tuberculosis, no suspicious symptoms of tuberculosis, no history of respiratory tract and recent respiratory symptoms, and no obvious abnormalities in both lungs on chest imaging (DR) examination; After consultation, there is no history of heart, liver, kidney, digestive tract, nervous system, or psychiatric abnormalities.

Exclusion Criteria

• Combined with the following serious diseases, such as advanced tumors, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, decompensated stage of congestive heart failure, autoimmune diseases (except those who do not need to use immune agents in the stable period), primary immunodeficiency diseases, etc.;
• Those suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, extensive skin diseases and allergies;
• Those with known or suspected (or high-risk occurrence possibility) immune impairment or abnormalities, such as those receiving immunosuppressants or immune booster therapy, receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract or blood products or plasma extracts within 1 month;
• Those who have positive human immunodeficiency virus (HIV) antibody test results;
• Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before this clinical trial;
• Fasting blood glucose ≥ 10mmol/L after drug control;
• Blood pressure range: systolic blood pressure ≥ 180 mmHg and (or) diastolic blood pressure ≥ 110 mmHg (those who take drugs are uncontrollable);
• Any situation that the investigator believes is poor adherence or may affect the evaluation of the trial.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuihua Lu, bachelor

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Locations

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Site Status: RECRUITING

Anhui Chest Hospital

Hefei, Anhui, China

Site Status: NOT_YET_RECRUITING

Guangzhou Municipal Hospital of Chest Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Site Status: RECRUITING

LiuZhou People's Hospital

Liuzhou, Guangxi, China

Site Status: RECRUITING

Changsha Central Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Wuxi NO.5 People's Hospital

Wuxi, Jiangsu, China

Site Status: RECRUITING

Wuhan Institute for Tuberculosis Control

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuihua Lu, bachelor

Role: CONTACT

lushuihua66@126.com

+86-18930811818

Lifeng Tao, Bachelor

Role: CONTACT

taolifeng@zhifeishengwu.com

+86-18110910397

Facility Contacts

Chengling Zhao

Role: primary

86-18105527755

Hua Wang

Role: primary

1726553540@qq.com

13395694530

HaiPing Dong

Role: primary

Shuihua Lu, Bachelor

Role: primary

lushuihua@shphc.org.cn

+86-18930811818

Chuan Qin, PostGraduate

Role: primary

Quest2009@126.com

13557223020

Yi Pei, Master

Role: primary

1113284116@qq.com

13755109302

XiuFeng Jiang

Role: primary

Baodong Yuan, Bachelor

Role: primary

490462008@qq.com

（86）13377858956

Other Identifiers

LKM-2022-EC01

Identifier Type: -

Identifier Source: org_study_id