Clinical Trial: Clinical Trial of Recombinant Hepatitis E Vaccine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
Brief Summary:
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.
The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.
The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.
Detailed Summary:
Participants were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study was carried out with two stages. In the first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited adverse events for 1 month after each injection. Serum samples from all the subjects were collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and monitored for solicited adverse events for 1 month after each injection. Serum samples from 9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events during the trial were followed up.
Suspected hepatitis cases were identified through an established active hepatitis surveillance system. The sentinels of the system comprised all the healthcare facilities in the field. Suspected hepatitis was defined as when patients presented with systemic symptoms such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV antibodies and HEV-RNA.
Sponsor: Xiamen University
Current Primary Outcome: Rate of confirmed hepatitis E cases [ Time Frame: One year since one month post the third injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- IgG anti-HEV seroconversion rate [ Time Frame: On one month post the third injection ]
- Persistency of IgG anti-HEV [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Xiamen University
Dates:
Date Received: November 13, 2009
Date Started: August 2007
Date Completion: June 2017
Last Updated: January 3, 2016
Last Verified: January 2016
