Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy
Status:
Completed
Trial end date:
2018-12-21
Target enrollment:
Participant gender:
Summary
Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but
only about 30-40% remain sustained response 1-3 years after discontinued therapy. The
investigators will try to improve the sustained response rate by given a course of HBV
vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir
therapy.
Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are
suppressed during entecavir or tenofovir therapy.
Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30
months will be invited to this study. The case group will receive 5 Engerix-B injections
during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group:
75 cases will be enrolled to receive Engerix-B injection and compared with histological
non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be
randomized into case (vaccine) and control group according to age, gender, pretreatment HBV
DNA level.
Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir
therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or
tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month
[30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be
discontinued after completed therapy.
Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative
HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy.
Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL
after discontinued nucleos(t)ide analogues therapy will be considered to have sustained
response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously
without further therapy will be defined as delayed response. Patients with persistent HBV DNA
greater than 1*100000 cps/mL will be considered to have non-sustained response.
Study duration: The enrollment will be completed in one year and keep on observation for
additional 2 years.
Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may
decrease the HBV relapse rate at 1 and 2 year after completed therapy.