An Open, Pared Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® in the Chronic Hepatitis B Patients on the Clinical Stability .( Aged 30 Years or Over)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose
研究概览
简要总结
This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
详细描述
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 the chronic Hepatitis B patients on the clinical stability and aged over 30 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •With clinical evidence of malignant tumor
- •History of severe cardio-cerebrovascular disease
- •Administration of hepatotoxicity drugs before or during the study
- •Pregnancy,breast-feeding or plan to be pregnant in 7 months later
- •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.
- •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 severe hypertension, cardiopathy,diabetes and hyperthyroidism)
- •Anomal 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 requie
- •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.
结局指标
主要结局
Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose
时间窗: Month 7
Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose
时间窗: Month 7
Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference.
次要结局
- Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose(Month 6-Month 7)
- Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose(Day 0-Month 1)
- Number of Participants Who Experienced Any Adverse Reactions/Events(Day 0-Month 7)
- Number of Participants Who Experienced Solicited Adverse Reactions/Events(Day 0-Day 7)
- Number of Participants Who Experienced Unsolicited Adverse Reactions/Events(Day 0-Month 7)
- Number of Participants Who Experienced Solicited System Adverse Reactions/Events(Day 0-Day 7)
- Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose(Day0-Month 7)
- Number of Participants Who Experienced Solicited Local Adverse Reactions/Events(Day 0-Day 7)