Hepatitis E Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
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.
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.
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