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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Xiamen Innovax Biotech Co., Ltd

Current Primary Outcome: Anti-HEV antibody of Experimental Group [ Time Frame: 7 months ]

Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Liver function of Experimental Group [ Time Frame: up to 7 months ]
    Measure the liver function before and after(after one month) the first and the third dose.
  • Adverse reactions/events of two groups [ Time Frame: up to 7 months ]
    Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study.
  • Anti-HEV antibody of Immunogenicity Control Group [ Time Frame: 7 months ]
    Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.


Original Secondary Outcome: Same as current

Information By: Xiamen Innovax Biotech Co., Ltd

Dates:
Date Received: November 9, 2016
Date Started: September 2016
Date Completion: May 2017
Last Updated: November 12, 2016
Last Verified: November 2016