Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine
研究概览
简要总结
A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in TASMC clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.
详细描述
participants 250 Single-center Research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. This estimate is based on a study published in the NEJM which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. the investigators estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received.
The study will include patients with chronic lymphocytic leukemia (CLL), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. The investigatorsexpect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 years and older
- •Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia
排除标准
- •Patients who have been previously vaccinated against RSV
- •Patients who have experienced a severe reaction to any vaccine in the past
结局指标
主要结局
To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine
时间窗: Up to 45 days post-vaccination
The response rate Is expected to be 60-70%
次要结局
- To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events(Up to 45 days post-vaccination)
- To identify factors predicting success/failure in achieving an antibody response to the vaccine.(Up to 1 year)
- To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.(Up to 1 year)