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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis E

Intervention / Treatment
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* Biological: 30μg/0.5ml Hepatitis E vaccine
* Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30μg/0.5ml Hepatitis E vaccine<br>three doses, 30μg/0.5ml per dose | Biological: 30μg/0.5ml Hepatitis E vaccine<br>* three doses, 30μg/0.5ml per dose<br>|
| Active Comparator: 30μg/0.5ml Recombinant Hepatitis E vaccine<br>30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co., Ltd. three doses, 30μg/0.5ml per dose | Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine<br>* 30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse reactions after vaccination | Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine. | within 7 days after each vaccination | 
| The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine | Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination | 7 months after the first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events after each vaccination | Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine. | within 28 days after each vaccination | 
| Occurrence of serious adverse events after the vaccination. | Occurrence of serious adverse events within 12 months after the first vaccination with the Hepatitis E vaccine. | within 12 months after the first vaccination | 
| The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine. | The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination. | 7 months after the first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, immunogenicity, Hepatitis E