A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
Condition: Hepatitis E
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Escherichia coli Infections; Hepatitis E; Hepatitis
Intervention: Recombinant Hepatitis E Vaccine (Escherichia Coli)
Intervention description: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 475.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis E

Summary:

      This phase IV clinical study was designed to evaluate the immunogenicity and safety of
      Hecolin® in the chronic Hepatitis B patients on the clinical stability.
    

Eligibility criteria:

        Inclusion Criteria(all volunteers):

          1. Aged over 30 years old on the day of enrollment

          2. Axillary temperature is below than 37.0 ℃.

          3. No administration of HEV vaccine before the study

          4. Judged as healthy and eligible for vaccination by the investigators through a
             selfreported medical history and some physical examinations.

          5. Able to understand this study information and willing to comply with all study
             requirements.

          6. Willing to participate in this study and sign informed consent form.

          7. Negative serological markers for hepatitis E

        Inclusion Criteria(experiment group):

          1. ALT < 1.5×ULN

          2. No spleen swelling,no cirrhosis and no hepatocellular carcinoma

        Inclusion Criteria(control group):

        1. HBsAg(-)

        Exclusion Criteria:

          1. With clinical evidence of malignant tumor

          2. History of severe cardio-cerebrovascular disease

          3. Administration of hepatotoxicity drugs before or during the study

          4. Pregnancy,breast-feeding or plan to be pregnant in 7 months later

          5. Participated in any other clinical trial during the study period.

          6. Use of any investigational product or non-registered product (drug or vaccine)within
             30 days preceding the first dose of the study vaccine or plan to use during the study
             period.

          7. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy
             for more than 14 days in the 6 months before entry, except local treatment.

          8. Administration of any immunoglobulin or blood products within 3 months preceding the
             first dose of the study vaccine,or plan to use during the study period.

          9. Administration of any inactivated vaccines within 14 days preceding the first dose of
             the study or attenuated live vaccines within 21 days preceding the first dose of the
             study.

         10. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring
             systemic antibiotics or antiviral treatment within 5 days before vaccination.

         11. Immunodeficiency (such as HIV carriers), primary disease of important organs,
             malignant tumor, or any immune disease (such as systemic lupus erythematosus,
             arthritis pauperum, splenectomy or functional asplenia or other disease which might
             affect immune response).

         12. History of allergic disease or history of serious adverse events occurring after
             vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.

         13. Allergic history to any component of this vaccine.

         14. Asthma that needed emergency treatment, hospitalization, oral or intravenous
             corticosteroid to keep stable in the past two years.

         15. Combining another severe internal medicine disease(such as severe hypertension,
             cardiopathy,diabetes and hyperthyroidism)

         16. Anomal coagulation function or coagulopathy diagnosed by doctor

         17. Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple
             epilepsy that do without curing within 3 years prior to the study )

         18. Anomal psychology or mind affecting the individual's ability to obey the study requie

         19. 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.