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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 1

Conditions

Hepatitis E

Treatments

Biological: 30μg/0.5ml Hepatitis E vaccine

Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT02603055

JSVCT025

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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