Clinical Trial of Recombinant Hepatitis E Vaccine

Inclusion Criteria:

• Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
• Subjects will reside in the study region in the next 19 months.
• Free of history of hepatitis B or hepatitis E.
• Can comply with the request of study.
• Axillary temperature is below 37 degree centigrade.

Exclusion Criteria:

For dose 1:

• Having other vaccine or immunoglobulin within two weeks;
• Having allergic history to vaccine and medicine
• Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
• Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
• Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors;
• congenital malformation, eccyliosis or severe chronic disease(e.g. Down Syndrome, diabetes, sickle cell anemia or mental disease);
• fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
• joining other clinical study undergoing;
• women pregnant or in lactation.

For dose 2 or 3:

• Severe allergy for dose 1 or 2;
• Severe adverse reaction associated with last vaccination;
• New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.