Status:

COMPLETED

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

Lead Sponsor:

Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Conditions:

HBV

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 f...

Detailed 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 patholo...

Eligibility Criteria

Inclusion

  • Patients over 18 years old
  • Multiple sclerosis or other known neurological disease (group 1), systemic vasculitis (group 2) or autoimmune disease (group 3)
  • Decision on treatment with anti-CD20 (rituximab or ocrelizumab)
  • Free and informed consent, oral
  • Negative hepatitis B serology.

Exclusion

  • Previous hepatitis B vaccination
  • Major disability
  • Pregnancy

Key Trial Info

Start Date :

September 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 15 2023

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04519710

Start Date

September 15 2020

End Date

October 15 2023

Last Update

February 2 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Valérie POURCHER

Paris, Île-de-France Region, France, 75013