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Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Indolent Lymphoproliferative Disorders

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Trial Information

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.


Inclusion Criteria:



- Age ≥ 18 years.

- Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low
tumor burden

- No indication of chemotherapy during the seven months of the vaccination protocol.

HBV serology negative for HBsAg / Ab HBs / HBc Ab.

- No history of vaccination against hepatitis B.

Exclusion Criteria:

- Indication of immediate chemotherapy.

- At least one HBV positive serologic marker .

- History of vaccination against HBV.

- Known neurodegenerative disease.

- Pregnancy.

- Febrile infection untreated.

- Known allergy to any vaccine component.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.

Outcome Time Frame:

Month 7

Safety Issue:

No

Principal Investigator

Pierre FEUGIER, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011-004968-30

NCT ID:

NCT01698866

Start Date:

July 2012

Completion Date:

July 2015

Related Keywords:

  • Indolent Lymphoproliferative Disorders
  • Low grade lymphoma
  • follicular lymphoma
  • indolent lymphoproliferative disorders
  • Vaccin GenHevac B Pasteur
  • Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma, Non-Hodgkin

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