Chronic hepatitis B
Conditions
Interventions
Experimental Group:TVAX-008: HBsAg 200µg + HBcAg 100µg + adjuvant 2 mg, intramuscular injection, once every 4 weeks for 4 or 6 doses.
Sponsors
Shandong Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form, understand this study and be willing to follow and have the ability to complete all research procedures; 2. Gender is not limited. Age range: 18 to 65 years old (including the threshold). 3. For patients with chronic hepatitis B who have not received antiviral treatment, HBsAg should be less than or equal to 20 IU/mL; Or HBsag-negative individuals without serological conversion (HBsAg < = 20 IU/mL at least 4 weeks interval; HBV DNA < 20 IU/mL; HBsAb < 10mIU/ml); 4. Anti-hbs antibody < 10 mIU/mL within 28 days before the first use of the study drug; 5. Serum ALT and AST should be less than or equal to 1.5×ULN within 28 days before the first use of the study drug. 6. Negative or abnormal antinuclear antibody (ANA), but the researcher determines that it does not support the diagnosis of autoimmune liver disease; 7. The pregnancy test results of female subjects must be negative or confirmed to be in a postmenopausal state. A pregnant woman with fertility must have a negative blood pregnancy test result and must not be in the lactation period. It is necessary to be willing to use effective contraceptive measures from the time of signing the informed consent form until the end of the study.
Exclusion criteria
Exclusion criteria: 1.In addition to chronic hepatitis B, suffering from clinically significant chronic diseases that the researcher deems unsuitable for the patient to participate in the study, such as: cardiovascular and cerebrovascular diseases, renal insufficiency, neuropsychiatric diseases, etc. 2. Laboratory indicators or symptoms meet one or more of the following: 1) Serum albumin 1.5×ULN; 3) Hemoglobin 1.5×ULN or creatinine clearance rate = 7.5%) or hypertension (systolic blood pressure > = 140 mmHg and/or diastolic blood pressure > = 90 mmHg); 10. Previous history of severe drug or food allergies; 11. Those who have been or are currently diagnosed with mental illness or severe depression; 12. Participated in another clinical trial of the investigational drug or biologics within 30 days before the first administration or within 5 drug half-lives; 13. Subjects who have used the study drug TVAX-008 injection within the past one year; 14. Those who have received immunoglobulin, blood or blood-related products within the past three months, or those who have been used during the planned study period; 15. The researcher believes that for other reasons, it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with anti-HBS antibodies>= 100mIU/mL;Positive conversion rate of anti-HBS antibody (proportion of subjects with anti-HBS antibody >=10mIU/L);HBsAg;Geometric mean concentration of anti-HBS antibody;Time to produce anti-HBS antibodies;Proportion of subjects with sustained clinical cure(persistent clearance of HBsAg and persistent undetectable HBV-DNA);Proportion of subjects with HBsAg reversal(HBsAg>=0.05IU/mL);Proportion of subjects with HBV-DNA reactivation(HBV DNA >==20IU/mL);Proportion of subjects with clinical relapse (HBsAg>=0.05IU/mL, HBV DNA>=2000IU/mL, ALT>=80U/L, except for ALT elevation due to other causes);Vital signs (diastolic, systolic, pulse, breathing, and body temperature);12-lead electrocardiogram;Clinical laboratory examination (blood routine, blood biochemistry);Adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZong Zhang
Shandong Public Health Clinical Center
Outcome results
None listed