NCT03168412已完成4 期
A Study on Immunogenicity of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® Using Accelerated Vaccination Schedule in Adults (Aged Over 18 Years)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Anti-HEV antibody of Experimental Group
研究概览
简要总结
This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or a 0-1-6 month schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 18 years old on the day of enrollment, including 18 years old;
- •Axillary temperature is below than 37.0 ℃;
- •Negative serological markers for hepatitis E and liver function are normal or no clinical significance;
- •Judged as healthy and eligible for vaccination by the investigators through a selfreported 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.
排除标准
- •Pregnancy,breast-feeding or plan to be pregnant in 7 months;
- •Administration of Hepatitis E Vaccine before the study;
- •Participate 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, or use 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), liver and kidney disease and other chronic disease history;
- •History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Allergic history to any component of this vaccine.
- •Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
- •Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism)
- •Anormal coagulation function or coagulopathy diagnosed by doctor;
- •Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that do without curing within 3 years prior to the study )
- •Anomal psychology or mind affecting the individual's ability to obey the study requirement;
- •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.
研究组 & 干预措施
the Accelerated Vaccination Schedule Group
Experimental
Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,7,21 day.
干预措施: Recombinant Hepatitis E Vaccine (Escherichia Coli) (Biological)
the Standard Vaccination Schedule Group
Active Comparator
Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.
干预措施: Recombinant Hepatitis E Vaccine (Escherichia Coli) (Biological)
结局指标
主要结局
Anti-HEV antibody of Experimental Group
时间窗: up to 2 months
Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine.
次要结局
- Adverse reactions/events of Experimental Group and Control Group(up to 7 months)
- Anti-HEV antibody of Experimental Group(up to 7 months)
- Anti-HEV antibody of Control Group(up to 7 months)
研究者
研究点 (1)
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