Chronic viral hepatitis B
Conditions
Interventions
CHB-1:Hepatitis E vaccine
CHB-2:Hepatitis E vaccine
CHB-3(Compensatory cirrhosis):Hepatitis E vaccine
Healthy control group:Hepatitis E vaccine
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects shall meet the following conditions (general conditions): 1) Aged above 18 years; 2) No previous history of hepatitis e vaccination, Anti-HEV-IgG and IgM are negative; 3) Women whose urine pregnancy test negative; 4) The subject himself can comply with the requirements of the clinical trial program and complete all studies program; 5) Sign the informed consent. 6) Subaxillary body temperature 100IU/ml, HBVDNA > 1.0e+3IU/ml, and ALT was lower than the upper limit of normal value (ULN). 3) Ultrasound examination showed no imaging manifestations of liver cirrhosis, liver cancer and portal hypertension; Group 2 of Chronic hepatitis B: 1) Patient diagnosed as chronic viral hepatitis B is being treated with oral nucleoside (acid) analogues 2) HBsAg > 100IU/ml within 3 months, ALT 10IU/ml within 3 months, ALT< ULN.HBVDNA < 100Iu/ml,Child grade A; 3) There is no history of cirrhotic complications, such as esophageal and gastric fundus variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, etc. 4) Ultrasound suggested no imaging manifestations of liver cancer; 4. The healthy control group still needs to meet the following requirements under the general conditions: 1) No chronic liver disease except non - alcoholic fatty liver disease (Exclusion of viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, drug-induced hepatitis, etc.); 2) HBsAg negative; 3) ALT, AST and TBIL are normal.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed or untreated malignant tumor; 2) Those who have history of severe cardiovascular disease; 3) Those who taking drugs with hepatotoxicity; 4) Pregnant women,lactating women or persons who recently planned pregnancy; 5) Persons who have used or plan to use any unregistered drug within 30 days prior to the first inoculation and during the observation period; 6) Long-term (lasting more than 14 days) use of immunosuppressants or other immunomodulatory drugs, systemic use of corticosteroids within 6 months before the first injection, but except for topical use (such as ointment, eye drops, inhalant or nasal spray); 7) Injection of immunoglobulin or any blood product within 3 months before admission, or planned to use during the trial (within 7months after immunization); 8) Person who had fever within 3 days prior to vaccination (axillary temperature >= 38.0 degree C) or had any acute illness or systemic application of antibiotics or antiviral therapy (except hepatitis b antiviral therapy) within the past 5 days; 9) Patients with immunodeficiency diseases such as HIV positive and important organs have primary disease, cancer or precancerous lesions, autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, any result without a spleen or splenectomy and other researchers think that may have an effect on the immune response of autoimmune disease), chronic hepatitis b and other kidney disease outside of nonalcoholic fatty liver disease and other chronic illness; 10) Those who have a history of allergies, including severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema or abdominal pain, or are allergic to any of the components of the observed vaccine. 11) Patients with asthma, unstable in the past two years requiring emergency treatment, hospitalization, oral or intravenous administration of cortico12 steroids; 12) Complicated with other serious medical diseases other than chronic hepatitis b, such as severe hypertension, heart disease, diabetes, hyperthyroidism, etc.; 13) With abnormal clotting function (such as lack of clotting factor, clotting disease, abnormal platelet) or clotting disorder diagnosed by doctors; 14) Patients with epilepsy, excluding alcoholic epilepsy in the first 3 years of abstinence or simple epilepsy without treatment in the past 3 years; 15) The psychological situation can not comply with the research requirements; 16) Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent. Exclusion criteria for second and third vaccinations: 1) Persons with severe allergic reaction at the first or second vaccination; 2) Persons with serious adverse reactions that have causal relationship with the previous vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| alamine aminotransferase;aspartate transaminase;total bilirubin;serum creatinine;Prothrombin time;Serum anti-hev-igg titer;Fibroscan;Albumin;Globulin;Urea nitrogen; | — |
Countries
China
Contacts
Public ContactWang Fang
The Third people's Hospital of Shenzhen
Outcome results
None listed