Liver transplant recipients after liver transplantation
Conditions
Interventions
Regular dose group:Routine 30ug dose of recombinant hepatitis E vaccine (Xiamen Wantai Canghai Bio-technology Co.
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Time after liver transplantation 6 months to 18 months; 2. No history of hepatitis E vaccination or infection, negative for anti-HEV antibodies (including anti-HEV IgM and IgG) and negative for HEV pathogens (HEV RNA and HEV antigen); 3. Normal or essentially normal liver and kidney function (indicators not elevated more than twice the normal value); 4. No rejection at the time of vaccination, no recent (within 1 month) infection; 5. In a state of mild immunosuppression, i.e. on a single immunosuppressant, or a small dose combination of two or more immunosuppressants, and off hormones for at least six months; 6. Fully understand the experimental research process and sign the informed consent form. 7. 18 years old <= age <= 70 years old, male or female;
Exclusion criteria
Exclusion criteria: 1. Time since liver transplantation 18 months; 2. Recurrence of combined primary disease (including recurrence of hepatitis B, recurrence of hepatocellular carcinoma, etc.); 3. Development of biliary complications: biliary strictures, bile leaks, bile sludge formation, ischaemic changes; 4. Vascular complications: stenosis, haemorrhage, thrombosis of the hepatic artery, portal vein or inferior vena cava. 5. Combined with significant abnormalities of liver function (elevated indexes more than two times the normal value or more); 6. Combined renal insufficiency requiring dialysis treatment; 7. Those with definite organic heart disease or arrhythmia; 8. Women who have a positive pregnancy test or who are breastfeeding, or who plan to become pregnant in the next 7 months; 9. Persons with a clear history of hypersensitivity to any component of the vaccine; 10. Contraindications to the trial vaccine insert: allergy to any component of the vaccine; history of allergy to other vaccines; thrombocytopenia or other coagulation disorders; history of allergy to kanamycin or other aminoglycosides; acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, and fever; uncontrolled epilepsy and other progressive neurological disorders; meets the conditions.One of the following; 11. Age 70 years;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of subjects after hepatitis E vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis E Virus IgG Antibody Test;Dynamic changes in cytokine levels;Mass Cytometry (CyTOF)-Based Immune Cell Subset Profiling, Functional Characterization, and Signaling Pathway Analysis; | — |
Countries
China
Contacts
Public ContactOuyang YaBo
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed