tuberculosis
Conditions
Interventions
Treatment group:The subjects will receive six dose levels of 50 µ g, 100 µ g, 125 µ g, 150 µ g, 200 µ g, and 250 µ g, with the immunization program consisting of two doses administered every month
At a dose level of 100ug, an additional immune program will be explored, which involves administering two doses every two months
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18-59 years old (including boundary values), gender not limited; 2. Agree to participate in this study and sign the informed consent form, comply with the requirements of the clinical research protocol, and complete the clinical study; 3. Subjects who have no history of tuberculosis in the past, and who have no clinical symptoms of active tuberculosis as judged by the researcher, and have no pathological changes consistent with active tuberculosis as confirmed by imaging, are excluded from mycobacterial tuberculosis infection by gamma interferon release test (IGRA) and tuberculin test (PPD); 4. Chest X-ray examination results show no abnormalities; 5. Vital sign examination (reference range for vital signs: systolic blood pressure 90~140mmHg, diastolic blood pressure 60~90mmHg, pulse 50~100 beats/minute, body temperature (axillary temperature)= 500 cells/µ L; 7. Female participants must meet the following criteria: surgical sterilization or postmenopausal for = 2 years, or a negative pregnancy test for women of childbearing age (premenopausal or postmenopausal<2 years), and be willing to take effective contraceptive measures during the study period and within 12 months after full immunization (such as Condoms are not allowed to be used alone with contraceptive pills. 8. Male participants must meet the following criteria: if they have not undergone sterilization surgery and have engaged in sexual activity that may lead to pregnancy, they agree to use effective contraceptive measures (such as condoms) during the study period and within 12 months after full immunization.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of vaccine allergies or allergies to any component of the investigational drug; 2. Individuals with known or suspected (or high-risk) immune dysfunction or abnormalities, such as those receiving immunosuppressive therapy (such as long-term use of systemic corticosteroids for >= 14 days, dose >= 2mg/kg/day or >= 20mg/day of prednisone or equivalent prednisone dose) (excluding inhaled, intra-articular, and local steroid use) or immune enhancer therapy, and those receiving immunoglobulin preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months; 3. Acute febrile diseases, infectious diseases (including but not limited to measles, whooping cough, influenza, etc.), diabetes with complications, acute or progressive liver disease or kidney disease, acute conjunctivitis, acute otitis media, severe heart disease, severe hypertension, myocardial damage, significant vascular sclerosis, endocarditis, cancer patients, etc; 4. Individuals with a history of seizures, epilepsy, encephalopathy (such as congenital brain hypoplasia, traumatic brain injury, brain tumors, cerebral hemorrhage, cerebral infarction, brain infections, chemical drug poisoning, etc.), and psychiatric disorders or a family history of psychiatric disorders; 5. Patients with splenomegaly or functional splenomegaly, as well as those with splenomegaly or splenectomy caused by any circumstances; 6. Patients with active viral hepatitis and/or HIV antibody positive human immunodeficiency virus and/or current or previous syphilis; Individuals with primary or secondary immune dysfunction or diagnosed with congenital or acquired immunodeficiency, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases; Within the first 3 days before enrollment, there was a fever (axillary temperature = 38.0 ?), and within the first 7 days, there was an acute disease requiring systemic antibiotic or antiviral treatment, or in the acute phase of chronic infection; 8. Women who are breastfeeding, pregnant, or planning to conceive during the study period, or men who plan to conceive their partners during the study period; 9. Those who drink more than 14 units (1 unit=17.7 mL ethanol, that is, 1 unit=357 mL beer with 5% alcohol, 43 mL Baijiu with 40% alcohol, or 147 mL wine with 12% alcohol) per week in the three months before screening, or cannot abstain from drinking during the test; 10. Screening for individuals with a history of drug abuse within the past 6 months; 11. Have received any vaccine within 14 days prior to vaccination or have received live attenuated vaccine within 28 days prior to vaccination; 12. Have participated in clinical trials of other drugs, medical devices, or vaccines within 3 months prior to the first dose of the trial vaccine; 13. The researchers believe that there are other circumstances in which the subjects are not suitable to participate in this study, including but not limited to those who cannot participate in follow-up according to the study protocol or those whose health status is deemed unstable by the researchers during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of adverse events/reactions 0-14 days after each dose of RH119 vaccination;Collection of adverse events/reactions 0-28 days after each dose of RH119 vaccination;The incidence of SAE and Adverse Events of Special Interest (AESI) within 6 months after the final dose of RH119 vaccination and the full course of vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence and rate of abnormal laboratory indicators in subjects ;The proportion of CD4+/CD8+T cells expressing specific cytokines (IFN - ?, IL-2, TNF - a, and IL-4) ;The expression levels of RH119 specific antibodies ; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Outcome results
None listed