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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 :
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-muscular vaccination (Group 1) | Active Comparator | This group corresponds to the use of the vaccine as used in the current recommendations. |
|
| Intra-dermal vaccination group without application of IMIQUIMOD cream (Group 2) | Active Comparator | Administration mode change for Intra-dermal vaccination. ( Instead of Intra-musculaire ) , to have a comparative with the experimental group. |
|
| Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3) | Experimental | Intra-dermal vaccin administration, with an immunity booster few minutes before by IMIQUIMOD application cream. Experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMIQUIMOD cream | Drug | Cream to apply before intra-dermal vaccine injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in each groups, with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine | Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0M1-M6 vaccine regimen using 3 vaccines strategies:
| 1 month of the last injection of vaccine, it means 1 month after the end of the total procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 1 month of the first injection (M1) with a vaccine regimen according to the vaccine strategy | Rate of patients with an anti-HB antibody level greater than 10mUI/mL at 1 month of the first injection (M1) with a vaccine regimen according to the vaccine strategy | 1 month of the first vaccine injection (Month 1) |
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Inclusion Criteria:
Adults (> 18 years old)
Exclusion Criteria:
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| HEPATITIS B SURFACE ANTIGEN | Biological | HBV Vaccine |
|
| Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 6 months of the first injection (M6) with a vaccine regimen according to the vaccine strategy | Rate of patients with an anti-HB antibody level greater than 10mUI/mL at 6 months of the first injection (M6) with a vaccine regimen according to the vaccine strategy | 6 months of the first vaccine injection (Month 6) |
| Describe the evolution of the level of anti-HBs antibodies between 2 successive visits according to the vaccine strategy |
| -Day 0 / Month 0 ; - Day 30 / Month 1 ; - Day 180 / Month 6 ; - Day 210 / Month 7 |
| Describe the rate of adverse events (by severity level) following the injection of a dose of intradermal vaccine | In each visit ( Month 1 , Month 6 , Month 7 ) we describe the rate of adverse events (by severity level) following the injection of a dose of intradermal vaccine | In each visit ( Month 1 , Month 6 , Month 7 ) |
| Describe the rate of adverse events (by severity level) following the injection of an intradermal vaccine dose after prior application of Imiquimod | In each visit ( Month 1 , Month 6 , Month 7 ) we describe the rate of adverse events (by severity level) after injection of an intradermal vaccine dose after prior application of Imiquimod | In each visit ( Month 1 , Month 6 , Month 7 ) |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006514 | Hepatitis B Surface Antigens |
| ID | Term |
|---|---|
| D006511 | Hepatitis B Antigens |
| D018963 | Hepatitis Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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