Hepatitis E
Conditions
Interventions
1:3 doses of recombinant hepatitis E vaccine in 0, 1, and 6 months
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with nonactive chronic hepatitis; 2. Patients with liver cirrhosis (ChildA-ChildB); 3. Have the nationality of the People's Republic of China; 4. Age over 18 years old; 5. Underarm body temperature <= 37 degrees C; 6. No previous history of hepatitis E vaccination, and anti-HEV-IgG and IgM are all negative; 7. With the knowledge and consent of the subject, and sign the "Informed Consent"; 8. Subjects can comply with the requirements of the research protocol;
Exclusion criteria
Exclusion criteria: 1. Identify patients with malignant tumors; 2. Liver transplant patients; 3. Patients with severe cardiovascular and cerebrovascular diseases and epilepsy; 4. Patients with serious underlying diseases (hypertension/diabetes/chronic bronchitis/chronic nephritis/hyperthyroidism/asthma, etc.) and patients with acute attacks; 5. A history of allergies, including those who have had serious adverse reactions from previous vaccination, such as allergies, urticaria, dyspnea, angioedema or abdominal pain, or those who are allergic to any of the components of the observation vaccine. 6. Patients with AIDS, tuberculosis, syphilis and other diseases; 7. Patients with positive urine pregnancy test during childbearing age; 8. Patients who are breast-feeding and planning to breast-feed; 9. Patients currently participating in other clinical trials; 10. Have a history of drug abuse and drug abuse; 11. Patients with mental illness who cannot clearly express their wishes; 12. The researcher may not be able to complete this project for any reason; 13. Platelets are less than 50 x 10^9/L; 14. Long-term (lasting more than 14 days) use of immunosuppressants or other immunomodulatory drugs, systemic medication of corticosteroids within 6 months before the first dose of vaccination, but local medications (such as ointments, eye drops, inhalants or Nasal spray); 15. Patients with serious complications such as gastrointestinal bleeding, hepatic encephalopathy, liver and kidney syndrome, massive ascites, severe infections; 16. Over 80 years old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ????; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactMei Xue
Shanghai Public Health Clinical Center
Outcome results
None listed