Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects
      and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10
      μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis
      patients, with 20 participants in each dosage group. Within 28 days after the skin test of
      the test drug, observations were made of reactions at the skin test site, reactions at
      non-skin test sites, concomitant medication, and any other physical discomfort (skin test
      site-specific reactions were recorded separately).
    

Detailed description: 
      The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects
      and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10
      μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis
      patients, with 20 participants in each dosage group.

      Enrollment will progress from low to high dosages, first with healthy subjects and then with
      pulmonary tuberculosis patients. The safety review committee (SRC) will review safety data
      before each dosage group escalates and before enrollment of tuberculosis patients. See the
      figure below for details.

      First, 10 healthy subjects will be enrolled in the low-dose group. After confirming the
      safety of the test drug within 72 hours of the skin test for all participants, the
      medium-dose group (10 participants) will be enrolled. After confirming the safety of the test
      drug within 72 hours of the skin test for all participants, the high-dose group (10
      participants) will be enrolled. Participants will receive a single intradermal injection of
      0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.After the
      last healthy subject in the low-dose group completes the 72-hour safety assessment following
      the skin test, pulmonary tuberculosis patients in the low-dose group can be enrolled
      simultaneously.

      Ten pulmonary tuberculosis patients will be enrolled in the low-dose group. After confirming
      the safety of the test drug within 72 hours of the skin test for all participants, the
      medium-dose group (10 participants) will be enrolled. After confirming the safety of the test
      drug within 72 hours of injection for all participants, the high-dose group (10 participants)
      will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the
      test drug using the Mantoux method on the volar aspect of the forearm.

      Within 28 days after the skin test of the test drug, observations were made of reactions at
      the skin test site, reactions at non-skin test sites, concomitant medication, and any other
      physical discomfort (skin test site-specific reactions were recorded separately).
    

Intervention name(s): Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)
Intervention type(s): Biological
Intervention description(s): 1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient.
Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tuberculosis