Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Latent Tuberculosis Infection
About this trial
This is an interventional diagnostic trial for Latent Tuberculosis Infection
Eligibility Criteria
Inclusion Criteria: People aged 6 months and above (≥6 months). Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above). I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol. Exclusion Criteria: Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial. Participated in other new drug clinical trials within 3 months prior to clinical trials. Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Sites / Locations
- Guangxi Zhuang Autonomous Region Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort 1
Cohort 2
Recombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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 (TB-PPD) : Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method.
Recombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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.