decompensated hepatitis B-related cirrhosis
Conditions
Interventions
decompensated CHB cirrhosis group:Hepatitis E vaccination
Compensated CHB cirrhosis group:Hepatitis E vaccination
Stable chronic hepatitis B group:Hepatitis E vaccination
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.General Inclusion Criteria (1)Aged 18 years or older at the time of the first vaccine dose; (2)No prior history of hepatitis E vaccine administration; (3)Negative urine pregnancy test for female participants; (4)Voluntary informed consent obtained from the study participant and signed Informed Consent Form; (5)Ability of the study participant to comply with the requirements of the study protocol; (6)Axillary body temperature = 37 ?; (7)Meeting the Chinese diagnostic criteria for chronic viral hepatitis B; (8)ALT level less than 2 times the upper limit of normal; (9)Negative results for both anti-HEV IgG and anti-HEV IgM in serum testing. 2.Specific Criteria (1)Compensated Cirrhosis Group (2)Meeting the diagnostic criteria for stage 1 (no varices or other complications) and stage 2 (with varices but no EGVB or ascites) of decompensated cirrhosis as defined in the 2023 Chinese Consensus on Clinical Diagnosis and Treatment of Cirrhosis;TBIL level less than 2 times the upper limit of normal; (3)Child-Pugh score 60 × 10?/L or prothrombin activity > 40%; (4)Child-Pugh score < 9.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for the First Vaccination (1) Patients with a confirmed diagnosis of malignant tumor; (2) Occurrence of acute decompensation events of cirrhosis within 1 month, including esophagogastric variceal bleeding, bacterial infection at a confirmed site (mainly pulmonary infection and peritonitis), grade 2 or 3 ascites, acute hepatic encephalopathy, and progressively worsening jaundice; (3) History of severe cardiovascular or cerebrovascular disease; (4) Use of hepatotoxic drugs, as judged by the clinician; (5) Females who are pregnant, lactating, or planning pregnancy in the near future; (6) Planning to participate in another clinical study simultaneously during the observation period; (7) Administration or planned administration of any other investigational or unregistered product (drug or vaccine) other than the study vaccine within 30 days before the first study vaccination, or during the observation period; (8) Long-term use (more than 14 consecutive days) of immunosuppressive agents, other immunomodulatory drugs, or systemic corticosteroids within 6 months before the first vaccination; topical use (e.g., ointments, eye drops, inhalants, or nasal sprays) is permitted; (9) Administration of immunoglobulin within 3 months before the first vaccination; (10) Vaccination with other vaccines within 14 days before enrollment in the study; (11) Fever (axillary temperature = 38.0?) within 3 days before vaccination, or any acute illness or systemic antibiotic/antiviral therapy (except anti-HBV antiviral therapy) within the past 5 days; (12) History of immunodeficiency diseases (e.g., HIV positivity), primary diseases of vital organs, cancer (or precancerous lesions), immune d. iseases (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy from any cause, and other immune diseases that may affect immune response as judged by the investigator), other chronic liver diseases such as HCV coinfection, autoimmune liver disease, alcoholic liver disease, inherited metabolic liver disease, drug-induced liver disease, as well as chronic kidney disease; (13) History of allergy, including severe adverse reactions to previous vaccination (such as anaphylaxis, urticaria, dyspnea, angioedema, or abdominal pain), or allergy to any component of the study vaccine; (14) History of allergy to kanamycin or other aminoglycoside drugs; (15) Asthma with unstable condition in the past two years, requiring emergency treatment, hospitalization, or oral/intravenous corticosteroids; (16) Complicated with severe uncontrolled internal diseases, such as severe hypertension, heart disease, diabetes mellitus, hyperthyroidism, etc.; (17) Epilepsy, excluding alcoholic epilepsy within 3 years before abstinence or simple epilepsy that does not require treatment in the past 3 years; (18) Psychological or mental abnormalities that prevent compliance with study-related requirements; (19) Any medical, psychological, social, occupational, or other conditions that, in the investigator’s judgment, are inconsistent with the study protocol or affect the participant’s ability to sign the informed consent. 2.Exclusion Criteria for the Second and Third Vaccinations (1) Participants who experienced severe allergic reactions during the first or second vaccination; (2) Participants who had severe adverse reactions causally related to the previous vaccination; (3) Participants newly diagnosed or developed conditions that meet the exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HEV-IgG seroconversion rate;Liver function changes pre- and post-vaccination;Collection of adverse events following vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| HEV-IgG Level (GMC) at 1M Post Complete Vaccination;HEV-IgG Level (GMC) at 12M Post Complete Vaccination;HEV-IgG Level (GMC) at 24M Post Complete Vaccination;HEV-IgG Level (GMC) at 1M After the Second Dose; | — |
Countries
China
Contacts
Public ContactLiao Xuejiao
Shenzhen Third People's Hospital
Outcome results
None listed