Chronic hepatitis B
Conditions
Interventions
Interventional group:Therapeutic Hepatitis B Vaccine
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)18 through 65 years of age(inclusive), male or female; 2)The diagnosis was in accordance with the diagnostic criteria of chronic hepatitis B in the "The guidelines of prevention and treatment for chronic hepatitis B (2019 version)" of the Chinese Medical Association; 3)Patients who never received antiviral therapy; 4)Patients with total bilirubin = 100*10^9/L), serum albumin >=35 g/L, and no prior history of clinical hepatic decompensation (eg, liver cirrhosis, hepatic encephalopathy, hepatocellular carcinoma, variceal hemorrhage, splenomegaly, ascites) during screening; 5)Patients with haemoglobin >= 100 g/L, creatinine clearance > 50mL/min, neutrophils >=1.2*10^9/ L during screening; 6)FibroScan score <= 12.4 kPa within 6 months prior to screening or during screening, or proven not to have cirrhosis according to liver tissues within 12 months; 7)Patients (including partners) are willing to have no pregnancy program and take effective contraceptive measures voluntarily from the initiation of trial to 12 months after the last administration; 8)Patients who signed the informed consent form before the trial, had a full understanding of the trial content, process and possible adverse reactions, and were able to complete the study in accordance with the trial protocol.
Exclusion criteria
Exclusion criteria: 1) Patients with a-fetoprotein > 50 ng/ml or with evidence of suspected hepatocellular carcinoma or other types of liver cancer; 2) Patients with other liver diseases other than chronic hepatitis B: such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver, non-alcoholic fatty liver disease, cirrhosis, a1 antitrypsin deficiency, Wilson's disease; 3) Patients with positive hepatitis C antibody, hepatitis D antibody, HIV antibody, or Treponema pallidum antibody during screening; 4) Patients who had been treated with immunosuppressants, immunomodulators, or corticosteroids (except topical or inhaled) within 6 months prior to screening; 5) Patients who have used any drug that can alter the enzyme activity of liver such as inhibitors or inducers of CYP3A4, P-gp or Bcrp, eg, itraconazole, ketoconazole or dronedarone (except for topical use) within 28 days prior to screening; 6) Patients who have a history of allergy to investigational medical product or its excipients, or susceptible to allergies (multiple drugs and food allergy); 7) Patients who have serious cardiovascular system disorders history: Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade II-III atrioventricular block, QTc interval > 480 ms, etc; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other >= grade 3 cardio-cerebrovascular events occurred within 6 months prior to the first dose; >= class 2 by New York Heart Association (NYHA) classification of heart failure or left ventricular ejection fraction (LVEF =14 units of alcohol per week; 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 10) History of drug abuse or use of narcotic drugs during the past five years; 11) Patients who have participated in any clinical trial within 3 months prior to the use of the study drug; 12) Female patients who are pregnant, breast-feeding or positive result of blood pregnancy test; 13) Patients who have other serious systemic diseases or in other conditions that are considered unsuitable for this study by the investigato.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Serious Adverse Events;Acute reaction at the injection site; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg quantitative levels;HBeAg quantitative levels;HBsAb quantitative levels; HBV-DNA quantitative levels;Immune response ;Changes of cytokines;Antigen-specific T cell immune response;RNA-seq signaling pathways;Single cell sequencing;Pharmacokinetics characteristics; | — |
Countries
China
Contacts
Public ContactWuhong
Changzhi People's Hospital
Outcome results
None listed