Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
时间窗: Month 7
次要结局
- To study the influence of age on the rate of seroconversion.(Month 0, Month 2 and Month 7)
- Describe the cellular immune response post vaccination 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)
- Describe vaccine-tolerance at M2 and M7.(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)
- - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.(Month 2)