Prospective Evaluation of COVID-19 Vaccine Induced Immunity
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Systemic and nasal antibody responses
研究概览
简要总结
This study aims to address the following three objectives:
- Longitudinal evaluation of the development of CMI responses in response to SARS-CoV-2 Vaccine: T cells isolated from the blood of COVID-19 vaccine recipients will be evaluated for their functionality in response to vaccine antigens. The temporal and functional properties of CMI responses will be correlated with the humoral or antibody responsiveness. CMI responses will be measured in vaccine recipients prior to vaccination to determine whether the presence or functionality of pre-existing responses to common cold coronaviruses (CCCs) or previous SARS-CoV-2 infections affect the development of CMI responses to the COVID-19 vaccine.
- Identification of cellular and soluble factors that influence vaccine responsiveness:
While it is known that poor clinical outcomes in COVID-19 patients are strongly associated with markers of systemic inflammation, the influence these systemic markers will have on COVID-19 vaccine responsiveness is not clear. Using systems biology approaches, the investigators will perform comprehensive profiling of cellular immune subsets, inflammatory signatures to identify determinants influencing the development of CMI responses to vaccine. 3. Examine variability of immune and viral genes and their relationship to vaccine induced immune responses: Human leukocyte antigen (HLA), T cell receptor (TCR) and B cell receptor (BCR) proteins are highly genetically diverse and critical to development of protective immunity. The investigators will perform HLA sequencing on whole blood-derived DNA samples and TCR and BCR sequencing on sorted, SARS-CoV2 vaccine antigen-specific T cells and B cells, respectively, to assess how different sequence combinations impact the CMI responses to vaccine.
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
- 是
入选标准
- •all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
排除标准
- •individuals under 18 years of age
研究组 & 干预措施
Health care or laboratory-based workers
Healthy individuals about to receive any approved COVID-19 vaccine
干预措施: covid19 vaccine (Drug)
Outpatients
Outpatients about to receive any approved COVID-19 vaccine
干预措施: covid19 vaccine (Drug)
结局指标
主要结局
Systemic and nasal antibody responses
时间窗: Change from Baseline to 12 days post second vaccine dose
IgA and IgG responses to SARS-CoV-2
Nasal T cell responses
时间窗: Change from Baseline to 12 days post second vaccine dose
Phenotype of CD4 and CD8+ T cells measured by nasal swabs
Systemic T cell responses
时间窗: Change from Baseline to 12 days post second vaccine dose
Cytokine responsiveness to SARS-CoV-2-specific CD4 and CD8+ T cells in blood
次要结局
未报告次要终点
研究者
Lyle Mckinnon
Assistant Professor
University of Manitoba
