drugset / Trial / NCT05028322

Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen

NCT05028322

Phase 2 Unknown 60 enrolled Central Hospital, Nancy, France
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2021-11-01
Primary completion
2024-12-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepatitis B vaccine Vaccine Intramuscular
Subject Imiquimod Other / unclassified Topical