Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is
an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced
immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B
virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention
of hepatitis B reactivation is recommended like using nucleoside analog for patients with
chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative
patients. The published data about efficacy of hepatitis b vaccination in onco-haematology
are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B
vaccination in patients with lymphoproliferative disorder.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
Month 7
No
Pierre FEUGIER, MD, PhD
Principal Investigator
Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2011-004968-30
NCT01698866
July 2012
July 2015
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