Immunological Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine
研究概览
简要总结
For many patients with hematologic disorders and bone marrow failure, hematopoietic stem cell transplantation (HSCT) or cellular therapy (CART) offers a curative treatment option. Patients after SCT or CART have a variable period of immune deficiency in the post-treatment period. The response to vaccination may affect the outcome of the transplant patients. the immunogenicity of vaccines in this immunosuppressed population is uncertain and variable. HSCT and CAR-T recipients are in a COVID-19 high-risk group and conferring immunity by vaccination at the earliest effective timepoint is desirable. At present, the immunogenicity and efficacy of SARS-CoV-2 vaccines in immune-impaired patients including autologous and allogeneic HSCT recipients is unknown. Furthermore, the impact of GvHD and IST on SARS-CoV-2 vaccine immunogenicity is unknown. the investigators aim to evaluate the vaccination response to COVID vaccines after SCT and CART
详细描述
so for participants with SCT or CART who decide to get their vaccines, the investigators will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days In addition, also the investigators will collect CD4 and Total IgG which is the standard of care of these patients post SCT and CART
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any SCT or CART post COVID vaccine
排除标准
- 未提供
结局指标
主要结局
estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine
时间窗: up to one year post vaccine
次要结局
未报告次要终点
研究者
Shatha Farhan
MD clinical assistant professor
Henry Ford Health System