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

Phase 4

Completed

Conditions: Hepatitis E

Interventions: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Registration Number: NCT02964910

Lead Sponsor: Xiamen Innovax Biotech Co., Ltd

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 475

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the healthy volunteer	Recombinant Hepatitis E Vaccine (Escherichia Coli)	Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.
the chronic Hepatitis B patients	Recombinant Hepatitis E Vaccine (Escherichia Coli)	Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.

Primary Outcome Measures

Name	Time	Method
Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose	Month 6-Month 7	ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose	Day 0-Month 1	ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Number of Participants Who Experienced Any Adverse Reactions/Events	Day 0-Month 7	Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.
Number of Participants Who Experienced Solicited Adverse Reactions/Events	Day 0-Day 7	Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.
Number of Participants Who Experienced Unsolicited Adverse Reactions/Events	Day 0-Month 7	Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.
Number of Participants Who Experienced Solicited System Adverse Reactions/Events	Day 0-Day 7	Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose	Day0-Month 7	ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Number of Participants Who Experienced Solicited Local Adverse Reactions/Events	Day 0-Day 7	Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.