Cirrhosis, Liver Clinical Trial
Official title:
Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination After Topical Application of IMIQUIMOD, in Cirrhotics Patients, Who Did Not Respond to the Conventional Vaccine Regimen: a Pilot Study
In a population of cirrhotics patients who did not responde to an anti-HBV vaccination according to the recommended vaccination, the goal is to : Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies : - After simple intramuscular vaccine (IM) ( Control group ) - After simple intradermal vaccine - after IMIQUIMOD's application followed by intradermal vaccine administration The main hypothesis of this study is : IMIQUIMOD acts as an immunity booster, so the combination of IMIQUIMOD with an intra-dermal injection of the anti-HBV vaccine allows better acquisition of post-vaccination immunization.
This study will be in a population of Cirrhotic patients who have already received a HBV vaccination with a conventional regimen and who have not responded (characterized by a level of antibody Hbs < 10UI/ml at the end of the vaccine regimen). In current recommendations, up to 3 additional injections of HBV vaccine should be injected to obtain an antibody level> 10 mIU / ml. In this study, the investigator will describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies : - After simple intramuscular vaccine (IM) ( Control group ) - After simple intradermal vaccine - after IMIQUIMOD's application followed by intradermal vaccine administration ;
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