Low Grade Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.

Detailed Description
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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.

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

Conditions
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Indolent Lymphoproliferative Disorders

Intervention / Treatment
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* Biological: Vaccin GenHevac B Pasteur


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccin GenHevac B Pasteur<br>vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6 | Biological: Vaccin GenHevac B Pasteur<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L. |  | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L. |  | Month 2 | 
| Describe the cellular immune response post vaccination at M2 and M7. |  | Month 2 and Month 7 | 
| To study the influence of age on the rate of seroconversion. |  | Month 0, Month 2 and Month 7 | 
| Describe vaccine-tolerance at M2 and M7. |  | Month 2 and Month 7 | 
| To study the influence of sex on the rate of seroconversion. |  | Month 0, Month 2 and Month 7 | 
| To study the influence of lymphocyte count on the rate of seroconversion. |  | Month 0, Month 2 and Month 7 | 
| To study the influence of total immunoglobulin on the rate of seroconversion. |  | Month 0, Month 2 and Month 7 | 
| To study the influence of immunoglobulin M on the rate of seroconversion. |  | Month 0, Month 2 and Month 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur