Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-01-31
2021-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health care or laboratory-based workers
Healthy individuals about to receive any approved COVID-19 vaccine
covid19 vaccine
Vaccine
Outpatients
Outpatients about to receive any approved COVID-19 vaccine
covid19 vaccine
Vaccine
Interventions
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covid19 vaccine
Vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Public Health Agency of Canada (PHAC)
OTHER_GOV
Cadham Provincial Lab
UNKNOWN
University of Manitoba
OTHER
Responsible Party
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Lyle Mckinnon
Assistant Professor
Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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B2021:008
Identifier Type: -
Identifier Source: org_study_id
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