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)
Conditions
Brief summary
For each vaccine strategy: proportion of patients with an anti-HBs antibody level greater than 10mUI/mL at M7 from the initial injection.
Detailed description
1) For each vaccine strategy: proportion of patients for whom an anti- HBs antibody level greater than 10mUI/mL is found at M1 from the initial injection., 2) For each vaccine strategy: proportion of patients for whom an anti- HBs antibody level greater than 10mUI/mL is found at M6 from the initial injection., 3) For each vaccine strategy, the evolution of the HB antibody title (in mUI/mL) will be considered: - Between dosages made at M0 and M1 (before versus 1 month of the first injection) - Between dosages at M1 and M6 (before versus 5 months of the 2nd injection) - Between dosages at M6 and M7 (before versus 1 month of the 3rd injection), 4) In patients who received the intradermal vaccine without prior application of Imiquimod: number of side effects and sevre side effects immediately or delayed at the injection site in relation to the number of intradermal injections performed in these patients;, 5) In patients who received the intradermal vaccine after prior application of Imiquimod: the number of side effects and severe side effects immediately or delayed at the Imiquimod application area and injection site in relation to the number of intradermal injections after prior application of Imiquimod in these patients.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For each vaccine strategy: proportion of patients with an anti-HBs antibody level greater than 10mUI/mL at M7 from the initial injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) For each vaccine strategy: proportion of patients for whom an anti- HBs antibody level greater than 10mUI/mL is found at M1 from the initial injection., 2) For each vaccine strategy: proportion of patients for whom an anti- HBs antibody level greater than 10mUI/mL is found at M6 from the initial injection., 3) For each vaccine strategy, the evolution of the HB antibody title (in mUI/mL) will be considered: - Between dosages made at M0 and M1 (before versus 1 month of the first injection) - Between dosages at M1 and M6 (before versus 5 months of the 2nd injection) - Between dosages at M6 and M7 (before versus 1 month of the 3rd injection), 4) In patients who received the intradermal vaccine without prior application of Imiquimod: number of side effects and sevre side effects immediately or delayed at the injection site in relation to the number of intradermal injections performed in these patients;, 5) In patients who received the intradermal vaccine after prior application of Imiqui | — |
Countries
France