A Phase 4 interventional study of Recombinant Hepatitis E Vaccine (Escherichia Coli) and Recombinant Hepatitis E Vaccine (Escherichia Coli) in Hepatitis E, sponsored by Xiamen Innovax Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
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.
Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.
Also known as: Hecolin®
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Also known as: Hecolin®
Anti-HEV antibody of Experimental Group
Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: up to 2 months
Adverse reactions/events of Experimental Group and Control Group
Measure solicited local adverse reactions/events within 7 days after each vaccination; Measure solicited systematic adverse reactions/events within 7 days after each vaccination; Measure unsolicited adverse reactions/events within 30 days after vaccination; Measure serious adverse events occurred throughout the study(up to 7 months).
Time frame: up to 7 months
Anti-HEV antibody of Experimental Group
Measure anti-HEV antibody in serum samples at 21st day,28st day and month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: up to 7 months
Anti-HEV antibody of Control Group
Measure anti-HEV antibody in serum samples at month 1,2,7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: up to 7 months
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Xiamen Innovax Biotech Co., Ltd