Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients

Prior treatment

• Patients with known or suspected (or high-risk) immune function impairment or abnormality,For example, patients receiving immunosuppressive or immunobooster therapy, patients receiving glucocorticoids, immunoglobulin preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months, human immunodeficiency virus infection or related diseases.
• Before enrollment, the interval between inoculation of live attenuated vaccine is less than 28 days, and the interval between inoculation of other vaccines is less than 14 days.
• In the acute stage of disease or acute onset of chronic disease (3 days before skin test).
• People are participating in or has participated in any other clinical investigator within 3 months prior to this clinical study.
• Suspected or confirmed drug abuse or alcohol abuse.

Other illness

• Suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, extensive skin diseases and allergic constitution(A history of allergy to two or more drugs or foods, or a known allergy and scar constitution to this drug component).
• People have any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.
• Convulsion, epilepsy, history of mental illness and/or family history of mental illness.
• The test results of human immunodeficiency virus (HIV) antibody are positive.
• A clear history of hypertension.
• The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.

Age

• Infants (under one year of age) whose birth weight is less than 2.5kg, or premature or refractory infants.
• Infants (under 1 year of age) suffering from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases.

Other

• Pregnant or lactating women, or planning to become pregnant during the study period.
• persons with upper limb disabilities.

• Inclusion criteria for tuberculosis patients:
  • Subjects aged 15 \~ 65 years (including 15 and 65 years old) who are clinically diagnosed or diagnosed with tuberculosis.
  • Subjects under the age of 15 (excluding those under the age of 15) who are clinically diagnosed or diagnosed with tuberculosis.
  • I (and/or my guardian) agree to participate in the study and sign the informed consent.
  • I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.
• Inclusion criteria for patients with extrapulmonary tuberculosis:
  • The patient was diagnosed with extrapulmonary tuberculosis by epidemiology, clinical manifestations, imaging examination, etiology examination, pathology examination and other auxiliary examinations, and the tuberculosis focus involved other parts of the lung.Combined with the characteristics of this clinical study and field implementation, the inclusion of patients with extrapulmonary tuberculosis should meet the "chemotherapy intensification period not completed".
  • I (and/or my guardian) agree to participate in the study and sign the informed consent.
  • I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.