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RECRUITING
NCT05899179
PHASE3

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

Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Controlled Phase Ⅲ Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein (EC) for the Diagnosis of Mycobacterium Tuberculosis Infection in 65-year-olds and Above

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

780

Start Date

2023-08-03

Completion Date

2025-10-31

Last Updated

2025-04-13

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

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.

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.

Locations (8)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Chest Hospital

Hefei, Anhui, China

Guangzhou Municipal Hospital of Chest Medicine

Guangzhou, Guangdong, China

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

LiuZhou People's Hospital

Liuchow, Guangxi, China

Changsha Central Hospital

Changsha, Hunan, China

Wuxi NO.5 People's Hospital

Wuxi, Jiangsu, China

Wuhan Institute for Tuberculosis Control

Wuhan, China