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Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination after topical application of IMIQUIMOD, in cirrhotic patients, who did not respond to the conventional vaccine regimen: a pilot study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514605-61-00
Acronym
2020PI198
Enrollment
60
Registered
2024-06-26
Start date
2022-07-08
Completion date
2025-01-22
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

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

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026