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临床试验/NCT04713163
NCT04713163Unknown不适用

Prospective Evaluation of COVID-19 Vaccine Induced Immunity

University of Manitoba0 个研究点目标入组 200 人开始时间: 2021年1月最近更新:
适应症
干预措施
相关药物

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:

  1. 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.
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lyle Mckinnon

Assistant Professor

University of Manitoba

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