Tuberculosis
Conditions
Interventions
Experimental group:BCG for intradermal injection
Control group:placebo
Sponsors
Sichuan Center For Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6-65 years old, able to provide legal identification; 2. The guardian and/or I agree to participate in the trial, and have the ability to understand the research procedures and sign an informed consent form, and are willing and able to comply with the requirements of the research protocol; 3. The female agrees to have no birth plan within 180 days after participating in the research and voluntarily take effective contraceptive measures; 4. There is no contraindication to BCG vaccination; (1) Known allergy to any component of this vaccine; (2) Patients suffering from acute disease, severe chronic disease, acute attack of chronic disease and fever; (3) Immune deficiency, immunocompromised or undergoing immunosuppression Treatment; (4) patients with encephalopathy, uncontrolled epilepsy and other progressive neurological diseases; (5) pregnant women; (6) patients with eczema or other skin diseases), no history of tuberculosis; 5. There are no contraindications to the use of BCG-PPD and EC (patients suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, patients with extensive skin diseases and allergies); 6. According to the medical history, physical examination and laboratory index test results, the investigator judges to be healthy (for example: no history of tumor, abnormal laboratory index but no clinical significance); 7. The average diameter of BCG-PPD 48-hour skin test induration is less than 5mm and there is no double circle, blisters, necrosis and lymphangitis reaction. The average diameter of EC 48-hour skin test induration and redness is less than 5mm without blisters, necrosis, and lymphangitis. reaction.
Exclusion criteria
Exclusion criteria: (1) Any previous history of severe side effects from vaccines or drugs, such as urticaria, dyspnea, angioedema; (2) The interval between inoculation of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days; (3) Those who have a history of convulsions, epilepsy, mental illness and/or family history of mental illness; (4) Human immunodeficiency virus (HIV) antibody test results are positive; (5) Have received blood or blood-related products within 3 months before screening; (6) A history of drug abuse upon inquiry; (7) Women who are breastfeeding; (8) Those who have participated in other clinical trials in the past 3 months and used study drugs; (9) 6-17 years old systolic blood pressure >= 120mmHg and/or diastolic blood pressure >= 80 mmHg; 18-65 years old diastolic blood pressure >=90mmHg and/or systolic blood pressure >=140mmHg; (10) Those with axillary body temperature >= 37.3 degrees C; (11) Those with upper limb disabilities; (12) The investigator believes that the subject has any conditions that may affect the evaluation of the research purpose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin test results; | — |
Countries
China
Contacts
Public ContactTing Huang
Sichuan Center For Disease Control and Prevention
Outcome results
None listed