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Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
Conditions
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.
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