hepatitis B-related liver disease (cirrhosis, liver cancer, liver failure, etc.)
Conditions
Interventions
Test group (booster vaccine group):Recombinant Hepatitis B Vaccine 60ug for vaccination
Control group (routine vaccine group):Recombinant Hepatitis B Vaccine 20ug for vaccination
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = 18 months; 3. Primary disease is hepatitis B-related liver disease; 4. Postoperative prophylactic regimen using nucleoside analogs in combination with hepatitis B immunoglobulin; 5. No signs of recurrence of hepatitis B, i.e. serum hepatitis B surface antigen negative and hepatitis B virus DNA negative; 6. Normal or essentially normal hepatic and renal function (indicators not elevated by more than two times the normal value); 7. No rejection at the time of vaccination, no recent (within 1 month) infections; 8. In a state of mild immunosuppression, i.e., on a single immunosuppressive agent, or two or more immunosuppressive agents in low-dose combination, and off hormones for at least six months; 9. Fully understand the experimental research process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Age 70 years; 2.Time since liver transplant <18 months; 3.Recurrence of combined primary disease (including recurrence of hepatitis B, recurrence of hepatocellular carcinoma, etc.); 4.Development of biliary complications: biliary strictures, bile leaks, bile sludge formation, ischaemic changes; 5.Vascular complications: stenosis, haemorrhage, thrombosis of the hepatic artery, portal vein or inferior vena cava. 6.Combined other viral infections; 7.Combined with significant abnormalities of liver function (elevated indexes more than two times the normal value or more); 8.Combined renal insufficiency requiring dialysis treatment; 9.Definition of organic heart disease or arrhythmia; 10.Women with a positive pregnancy test or breastfeeding or men and women planning to have children in the near future; 11.Individuals with a clear history of hypersensitivity to any component of the vaccine;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis B surface antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;Biochemistry + Liver Function;T-cell subpopulation ;drug concentration; | — |
Countries
China
Contacts
Public ContactGuangming Li
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed