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To conduct a phase IV clinical trial of recombinant Mycobacterium tuberculosis fusion protein (EC) in community population aged 6 months and over

To conduct a phase IV clinical trial of recombinant Mycobacterium tuberculosis fusion protein (EC) in community population aged 6 months and over

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070447
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-04-19
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium tuberculosis infection

Interventions

Cohort 1:Blood samples were collected for specific ?-IFN (T-SPOT) detection, and then EC and TB-PPD skin tests were performed on both arms. One dose of the test drug was injected intradermally into th
Cohort 2:Subjects were tested for EC on single arm skin.

Sponsors

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 6 months and above (>=6 months), no gender limit; 2. Patients with normal armpit body temperature (< 37.5? from 6 months to 14 years old, < 37.3? from 15 years old and above); 3. The patient and/or guardian agree to participate in the study and sign the informed consent, and are willing and able to comply with the requirements of the clinical study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic constitution; 2. Use PPD or similar products within 3 months before clinical trial; 3. Participated in clinical trials of other new drugs within 3 months before clinical trials; 4. The investigator considered that there were any circumstances which might affect the evaluation of the test.

Design outcomes

Primary

MeasureTime frame
The number of millimeters (mm) in transverse and longitudinal diameters of the red halos;The number of millimeters (mm) in transverse and longitudinal diameters of indurations;

Countries

China

Contacts

Public ContactMo Yi

Guangxi Center for Disease Control and Prevention

moyi0415@qq.com+86 15778068886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026