A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China

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.

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