Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 neutralizing antibodies
研究概览
简要总结
This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.
详细描述
PRIMARY OBJECTIVE:
I. To establish the possibility of anti-SARS-CoV-2 adaptive immunity transfer from matched related (MRD) or unrelated (MUD) HCT donor to HCT recipient.
SECONDARY OBJECTIVES:
I. To explore anti-SARS-CoV-2 adaptive immunity transfer in the haploidentical (haplo) HCT setting.
II. To assess the prevalence and change over time of SARS-CoV-2 seropositive donors among all consented donors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL COHORTS: Documented written informed consent of the participant
- •ALL COHORTS: Recipients must have a planned allogeneic HCT procedure. MRD, MUD, and haplo HCT allowed. Usage of post-transplant cyclophosphamide (PTCy) permitted only in haplo setting
- •ALL COHORTS: GCSF-mobilized peripheral blood stem cell (PBSC) only as graft source
- •ALL COHORTS: Planned HCT with minimal to no-T cell depletion of graft for the treatment of the following hematologic malignancies:
- •Lymphoma (Hodgkin and non-Hodgkin)
- •Myelodysplastic syndrome
- •Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)
- •Acute myeloid leukemia in first or second remission
- •Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
- •Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis
- •ALL COHORTS: Willingness to
- •Provide blood samples and saliva specimens
- •Permit medical record review
- •ADDITIONAL CRITERIA FOR RECIPIENTS IN THE MAIN COHORT:
- •Absence of documented COVID-19 history and active COVID-19 infection
- •ADDITIONAL CRITERIA FOR RECIPIENTS IN THE REFERENCE COHORT: Active COVID-19 infection during HCT
排除标准
- 未提供
结局指标
主要结局
SARS-CoV-2 neutralizing antibodies
时间窗: Up to 180 days post-HCT
Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.
SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels
时间窗: Up to 180 days post-HCT
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.
Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels
时间窗: Up to 180 days post-hematopoietic stem cell transplant (HCT)
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.
次要结局
- SARS-CoV-2 IgA concentration(Up to 180 days post-HCT)