Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Official Title
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Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years

Conditions
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Hepatitis E

Intervention / Treatment
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* Biological: Recombinant (E. Coli) Hepatitis E Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form. Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study. Subjects will reside in the study region in the next 7 months. Free of history of hepatitis E. Can comply with the request of study. Axillary temperature is below 37 degree centigrade. Exclusion Criteria: For dose 1: receiving other vaccine or immunoglobulin within two weeks; Having serious 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, genetic defect, HIV or other factors; Congenital malformation, eccyliosis or severe chronic 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.

Ages Eligible for Study
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Minimum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Senior group(over 65 years old)-HE<br>Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. | Biological: Recombinant (E. Coli) Hepatitis E Vaccine<br> <br> * Other names: Hecolin®;|
| Active Comparator: Younger groups(16-65 years old)<br>Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. | Biological: Recombinant (E. Coli) Hepatitis E Vaccine<br> <br> * Other names: Hecolin®;|
| No Intervention: Senior group(over 65 years old)-Cont<br>Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events | Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded. | From month 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-HEV IgG seropositive rate |  | at month 7 | 
| GMT of anti-HEV IgG | Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested | 7 month after first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis E, Immunogenicity, vaccine, safety