A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations

Inclusion Criteria

1. Clinically Healthy participants aged 18-40 years;
2. Participants have been informed properly regarding the study and signed the informed consent form.
3. Participants will commit to comply with the instructions of the investigator and the schedule of the trial;
4. Participants must have a negative IGRA and sputum.
5. Clinically normal laboratory values for ureum, creatinine, SGOT, SGPT, complete blood count (CBC), urinalysis, coagulation test (PT, aPTT), total cholesterol, Globulin/Albumin ratio and CRP

Exclusion Criteria:

1. Those who are currently diagnosed with tuberculosis or have a history of tuberculosis (positive IGRA or GenXpert sputum test or chest Xray suggestive of TB) and/or history of tuberculosis treatment; including TB Preventive Treatment (TPT);
2. There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease;
3. Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of the chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc.; based on interview with participants
4. Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving more than 20mg/day of systemic glucocorticoids for 14 consecutive days within the last 4 weeks, immunosuppressants within 3 months, and Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months;
5. People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; history of bronchial asthma;
6. Current patients with HIV antibody positive for human immunodeficiency virus;
7. Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period;
8. Subjects receive any vaccination within 1 month before and after dosing;
9. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
10. Any other situation that the researcher believes may affect the evaluation of the research.