A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

Study Overview
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Brief Summary
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This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

Official Title
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Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years

Conditions
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Hepatitis E

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy people aged over 18 years old on the day of enrollment Axillary temperature is below than 37.0 ℃ Blood pressure is not higher than 160/100 mmHg (with or without any medicine) Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations. Able to understand this study information and willing to comply with all study requirements. Willing to participate in this study and sign informed consent form. Exclusion Criteria: Participated in any other clinical trial during the study period. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Pregnant or breastfeeding Allergic history to any component of this vaccine. Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. | Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)<br>* Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.<br>* Other names: Hecolin®;|
| Active Comparator: Immunogenicity Control Group<br>Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. | Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)<br>* Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.<br>* Other names: Hecolin®;|
| No Intervention: Safety Control Group<br>Participants in this arm are aged over 65 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions/events | Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study | up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HEV antibody | Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis E