SCIVAX：慢性 SCI 中免疫功能障碍和疫苗反应的生物标志物 (SCIVAX)
慢性创伤性脊髓损伤患者免疫功能障碍和疫苗反应的生物标志物
The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.
研究概览
地位
详细说明
The purpose of this research study is to measure a person's immune response to a vaccine by measuring types of circulating white blood cells (WBC) and the substances they produce in blood, including antibodies, proteins, and ribonucleic acids (the body's genetic blueprint for making proteins).
The research will study two populations: uninjured people and people living with spinal cord injury (SCI), who are often at increased risk of infections. We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level.
The overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu, and to the SARS-CoV-2 virus that causes COVID-19. There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection. Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI
研究类型
注册 (估计的)
联系人和位置
学习地点
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New York
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Manhasset、New York、美国、11030
- Northwell Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Participants will be adults (ages 18-89 years old) with SCI or who are uninjured controls who are electing to receiving flu or COVID-19 vaccines to promote their health.
描述
Inclusion Criteria
SCI Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:
- 18-89 years old with traumatic SCI
- initial traumatic SCI >/=1 year from enrollment (DOD funded study)
- initial traumatic SCI <1 year from enrollment (non-DOD funded pilot study)
- American Spinal Injury Association (ASIA) classification grade A-D
- Neurological Injury Level C1-T10
- Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.
Exclusion Criteria
To be eligible for prospective enrollment, SCI participants are required to not meet the following exclusion criteria:
- Stage III-IV pressure ulcers
- Cancer, chemotherapy, neutropenia
- Pregnancy or lactation
- No known SCI
- Autoimmune disease
- Pre-existing neurological disease
- History of dementia
- Any other condition that would compromise their ability to provide informed consent
- Any other condition that a study physician feels would preclude participation or be contraindicated
Uninjured Control Group:
Inclusion Criteria
Uninjured Control Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:
- 18-89 years old without traumatic SCI
- Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.
Exclusion Criteria
To be eligible for prospective enrollment, uninjured control participants are required to not meet the following exclusion criteria:
- Cancer, chemotherapy, neutropenia
- Pregnancy or lactation
- Autoimmune disease
- Pre-existing neurological disease
- History of dementia
- Any other condition that would compromise their ability to provide informed consent
- Any other condition that a study physician feels would preclude participation or be contraindicated
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
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Individuals with Chronic Spinal Cord Injury who receive either Flu or COVID-19 vaccine
18-89 years old with traumatic SCI, AIS grade A-D, Neurological injury level of C1-T10 who are choosing to receive a vaccine against the flu or COVID-19 and demonstrate capacity to provide informed consent. |
|
Uninjured Controls who receive the Flu vaccine or COVID-19 vaccine
18-89 years old without traumatic Spinal Cord Injury (SCI) who are choosing to receive a vaccine against either the Flu or COVID-19 and demonstrate the capacity to provide informed consent. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
大体时间：0-28 days after flu vaccination
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Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity. |
0-28 days after flu vaccination
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Anti-flu antibody titers in response to vaccination
大体时间：0-28 days after flu vaccination
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Serum samples will be used to determine antibody titers for anti-flu antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity |
0-28 days after flu vaccination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination
大体时间：0-28 days after COVID-19 vaccination
|
Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity. |
0-28 days after COVID-19 vaccination
|
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Anti-COVID-19 antibody titers in response to vaccination
大体时间：0-28 days after COVID-19 vaccination
|
Serum samples will be used to determine antibody titers for anti-COVID-19 antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity |
0-28 days after COVID-19 vaccination
|
|
Systemic inflammatory cytokine levels in response to vaccination
大体时间：0-28 days after vaccination
|
Serum samples will be used to determine systemic inflammatory cytokine levels at baseline and after flu or COVID-19 vaccination. These samples will be obtained to determine if cytokine levels are different between participant groups and within the SCI group by injury level and severity |
0-28 days after vaccination
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合作者和调查者
调查人员
- 首席研究员：Ona Bloom, PhD、Feinstein Institute for Medical Research; Northwell Health
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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