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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
475
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Rushan Center for Disease Control and Prevention
Weihai, Shandong, China
Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose
Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: Month 7
Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose
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.
Time frame: Month 7
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
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.
Time frame: Day 0-Month 1
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
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.
Time frame: Month 6-Month 7
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Day0-Month 7
Number of Participants Who Experienced Any Adverse Reactions/Events
Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.
Time frame: Day 0-Month 7
Number of Participants Who Experienced Solicited Adverse Reactions/Events
Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.
Time frame: Day 0-Day 7
Number of Participants Who Experienced Solicited Local Adverse Reactions/Events
Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.
Time frame: Day 0-Day 7
Number of Participants Who Experienced Solicited System Adverse Reactions/Events
Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.
Time frame: Day 0-Day 7
Number of Participants Who Experienced Unsolicited Adverse Reactions/Events
Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.
Time frame: Day 0-Month 7