a clinical trial to evaluate a recombinant hepatitis e vaccine in healthy adults

Conditions: Hepatitis E

Summary: hepatitis e is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. the investigational hepatitis e vaccine is a recombinant aluminium-adjuvant hepatitis e vaccine. this is a single center, randomized, blinding, parallel-controlled phase ib clinical trial. this study will determine the safety and immunogenicity of the investigational recombinant hepatitis e vaccine in healthy adults between 16 and 65 years.


Eligibility criteria:
inclusion criteria: * aged between 16 and 65 years with normal intelligence. * negative in antibody against hepatitis e test. * no plan to go out for a long time within 9 months. * able to understand the content of informed consent and willing to sign the informed consent * general good health as established by medical history and physical examination. * able and willing to complete all the secluded study process during the whole study follow-up period. * no history of hepatitis b, hepatitis c and hepatitis e(patients diagnosed as hepatitis b, hepatitis c and hepatitis e by town or above) * axillary temperature ≤37.0°c on the day of enrollment exclusion criteria: * woman who is pregnant, breast-feeding or planning to be pregnant during the study period * allergic history of any vaccination or drugs, or allergic to any ingredient of the hepatitis e vaccine * history of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain * autoimmune disease or immunodeficiency * asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years * type i or ii diabetes, not including gestational diabetes * history of thyroidectomy, or need treatment for thyroid disease in the past 12 months * history of serious angioneurotic edema in the past 3 years, or need treatment for it in the past 2 years * severe hypertension, with the blood pressure still more than 150/100 mmhg after drug maintenance treatment * abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by the doctor. * patients who are active or not have a definite cure of malignant tumors, or who may recur in the study period. * epilepsy, not including alcohol epilepsy in the first 3 years abstinence or simple epilepsy without the need of treatment in the past 3 years * asplenia or functional asplenia, or asplenia and splenectomy under any circumstances * guillain barre syndrome * prior administration of immunodepressant, cytotoxic or corticosteroids (not including corticosteroid therapy for allergic rhinitis and acute non concurrent dermatitis )treatment in last 6 months * prior administration of immune globulin in last 3 months * prior administration of other research medicines in last 1 month * prior administration of attenuated vaccine in last 1 month * prior administration of subunit or inactivated vaccine in last 14 days, such as pneumococcal vaccine * current anti-tuberculosis prophylaxis or therapy * fever (axillary temperature 38.0℃) in 3 days before vaccination or any acute disease, systemic application of antibiotics or antiviral therapy in the past five days * unable to comply with the study requirements due to the psychological situation, a past or present history of mental disease, two-stage affective psychosis which were not well controlled in the past two years; mental disease need medical treatment, and have suicidal tendency over the past five years * any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Keywords: safety immunogenicity hepatitis e