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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccin GenHevac B Pasteur | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccin GenHevac B Pasteur | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L. | Month 7 |
| 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 |
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Inclusion Criteria:
HBV serology negative for HBsAg / Ab HBs / HBc Ab.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre FEUGIER, MD, PhD | Contact | +33 3 83 15 32 82 | p.feugier@chu-nancy.fr | |
| Jessica MICHEL, MD | Contact | +33 3 83 15 53 49 | je.michel@chu-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre FEUGIER, MD, PhD | Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle Hématologie CHU Nancy Brabois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| 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 |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |