drugset / Trial / NCT05028322
Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Subject | Imiquimod | Other / unclassified | — | Topical |