Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HBV
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
An accelerated regimen allows healthy adults to obtain vaccine protection very quickly. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease requiring an anti-CD20 monoclonal antibody if the co...
An accelerated regimen allows healthy adults to obtain vaccine protection very quickly. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease requiring an anti-CD20 monoclonal antibody if the combination of injections over a short period is likely to promote immunization. The aim of this pilot, interventional study is to evaluate the anti-HBV vaccine response measured by the level of anti-HBs antibodies greater than 10 IU / l after vaccination in patients to receive treatment with anti-CD20. Evaluation of the specific anti-HBV vaccine response, measured by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 in patients having received a regimen accelerated by Engerix B 20 µg (D0, D7, J21), then recall 12 months later. Anti-CD20 drugs should be started at least 1 month after the first 3 injections for neurological pathologies and after the first 2 injections for vasculitis and autoimmune diseases (scheme linked to the underlying pathology with the need for rapid treatment with anti -CD20 in these pathologies). Follow-up of 3 parallel cohorts of patients seronegative for hepatitis B virus (HBV): 1 cohort followed for multiple sclerosis or another inflammatory neurological disease (group 1) the cohort followed for systemic vasculitis (group 2) 1 cohort followed for an autoimmune disease (RA, Lupus, etc.) (group 3) to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B. The patients will be followed for a period of 13 months after the start of the vaccination.
Tracking Information
- NCT #
- NCT04519710
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: valérie Pourcher, MD Pitie-Salpetriere Hospital