Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fold Rise in Antibody Titers and Seroconversion
研究概览
简要总结
This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.
The main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.
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 or older
- •Diagnosis of hematological malignancy
- •Treatment with HSCT or CAR-T therapy
- •Must be able to give informed consent
- •Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination
- •Must be willing to provide blood samples at four weeks and six months post-vaccination
- •Must have an insurance plan that covers the cost of recieving the RSV vaccine.
排除标准
- •History of a severe allergic reaction to any component of the RSV vaccine
- •Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months
研究组 & 干预措施
Vaccine Recipients
Patients who will recieve the RSV vaccine
干预措施: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) (Biological)
结局指标
主要结局
Fold Rise in Antibody Titers and Seroconversion
时间窗: From the time the patient receives the vaccine to four weeks post-vaccination.
The primary endpoint is the fold rise in antibody titers against the preF protein at four weeks post-vaccination compared to pre-vaccination (baseline) levels. An additional related objective is to assess whether patients are able to achieve seroconversion. The endpoint for this objective is the proportion of patients with at least a four-fold increase in neutralizing titers from the pre-vaccination baseline at four weeks post-vaccination.
次要结局
- COVID-19 and Influenza Immunity(From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.)
- Persistence of Humoral Immune Response(From four weeks post-vaccination to six months post-vaccination)
研究者
Anil Rengan
Assistant Professor of Medicine, Hematology/Oncology, Cooper University Health Care
Cooper University Health Care