A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
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.
This phase IV clinical study was designed to evaluate the immunogenicity and safety of the
 recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,
 in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age
 at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered
 intramuscularly according to a 0-1-6 month schedule.
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.