COVID-19 Vaccine Induced Immunity

Study Overview
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Brief Summary
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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. 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.

Official Title
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Prospective Evaluation of COVID-19 Vaccine Induced Immunity

Conditions
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Covid19

Intervention / Treatment
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* Drug: covid19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines. Exclusion Criteria: individuals under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health care or laboratory-based workers<br>Healthy individuals about to receive any approved COVID-19 vaccine | Drug: covid19 vaccine<br>* Vaccine<br>* Other names: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada;|
| Outpatients<br>Outpatients about to receive any approved COVID-19 vaccine | Drug: covid19 vaccine<br>* Vaccine<br>* Other names: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal T cell responses | Phenotype of CD4 and CD8+ T cells measured by nasal swabs | Change from Baseline to 12 days post second vaccine dose | 
| Systemic T cell responses | Cytokine responsiveness to SARS-CoV-2-specific CD4 and CD8+ T cells in blood | Change from Baseline to 12 days post second vaccine dose | 
| Systemic and nasal antibody responses | IgA and IgG responses to SARS-CoV-2 | Change from Baseline to 12 days post second vaccine dose |