tuberculosis
Conditions
Interventions
1:recombinant Mycobacterium tuberculosis (TB) 11 kDa protein
Sponsors
Beijing Tuberculosis and Thoracic Tumor Research Insititute
Eligibility
Sex/Gender
Male
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers: (1) No pulmonary and extrapulmonary tuberculosis (TB), no respiratory or other systemic symptoms; (2) No acute or chronic diseases, no acute infectious disease, no skin disease or skin allergy to various causes; (3) No close contact with individuals with TB; and (4) No TB lesions as confirmed by chest X-ray. 2.Patients with pulmonary TB, including those with initially-treated TB, those with recurrent or persistent TB after treatment, and those with bacteria positive or negative TB: (1) Initially-treated pulmonary TB: patients with no previous anti-TB treatment; or with irregular treatment or anti-TB chemotherapy less than one month; (2) Recurrent or persistent pulmonary TB:Patients who failed initial treatment; Recurrence after initial treatment for a complete course; continuous positivity in the sputum duration of 1-2 years without formal chemotherapy; occurrence of new lesions or recurrence or deterioration of the lesions after lung resection; (3) Bacteria positive and Bacteria negative TB: Bacteria positive positive pulmonary TB, 1 to 3 months before the test, sputum smear showing acid-fast bacilli and/ or culture positive for M. tuberculosis. Bacteria negative pulmonary TB, sputum continuously negative 3 months before the test, but with three of the following items 1-6 or one of items 7 and 8: 1) typical clinical symptoms and the appearance of chest X-ray; 2) effective anti-TB treatment; 3) clinically, other non-tuberculous lung disease ruled out; 4) strong positivity for 5 units of PPD-T, or positivity for serum anti-TB antibodies; 5) Positive sputum PCR and Probe; 6) Extrapulmonary TB lesions confirmed by pathology; 7) acid-fast mycobacteria detected by BALF; and 8) Bronchus or lung TB confirmed by pathology. 3.Patients with cured TB: (1) Patients who became sputum negative with healed lesions or without active disease after chemotherapy; (2) Patients without occurrence of new lesions or recurrence / deterioration of the lesions after pulmonary surgery; and (3) those with cured TB for more than 2 years without recurrence.
Exclusion criteria
Exclusion criteria: 1. The healthy group: those with close contact with TB patients, especially with active TB 3 weeks prior to the recruitment; 2. Patients with diseases in major organs, autoimmune diseases, organ transplantation, or treated with immunosuppressants or immunostimulants, or long-term use of hormones; 3. Patients with human immunodeficiency virus infection or related diseases; 4. Patients suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, epilepsy, neurological diseases and ventilation history; 5. Subjects participating in other clinical studies; 6. Pregnant and breast-feeding women; 7. Subjects allergic to two or more drugs, with a history of food allergy, or known to be allergic to the components of substances used in this study; 8. Subjects who would need to receive other vaccines during the study; 9. Subjects with suspected alcohol, drug abuse history (including alcoholics); 10. Subjects with the high possibility of drop-out due to general physical conditions, or with situations that may affect the data analysis in the study, as judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin test reaction size; | — |
Countries
China
Contacts
Public ContactGao Meng-qiu
Beijing Chest Hospital
Outcome results
None listed