Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies

Conditions

• HBV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B — BIOLOGICAL
  to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

Study Details

Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients. However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease. For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization. The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (\> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.

Key Dates

Start date

Sep 15, 2020

Status verified

Feb 2024

Primary completion

Sep 15, 2021

Completion

Oct 15, 2023

Study Design

Enrollment

60 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: multiple sclerosis or other inflammatory neurological disease
  HBV negative
• Experimental: systemic vasculitis
  HBV negative
• Experimental: an autoimmune disease
  HBV negative

Primary Outcome Measure

Measure of the specific anti-HBV vaccine response, assessed by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 [ Time Frame: 13 months ]