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COVID-19 Vaccine Induced Immunity

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04713163
Collaborator
Public Health Agency of Canada (PHAC) (Other), Cadham Provincial Lab (Other)
200
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Drug: covid19 vaccine

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of COVID-19 Vaccine Induced Immunity
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Health care or laboratory-based workers

Healthy individuals about to receive any approved COVID-19 vaccine

Drug: covid19 vaccine
Vaccine
Other Names:
  • moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada

    		•
    Outpatients

    Outpatients about to receive any approved COVID-19 vaccine

    Drug: covid19 vaccine
    Vaccine
    Other Names:
  • moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nasal T cell responses [Change from Baseline to 12 days post second vaccine dose]

      Phenotype of CD4 and CD8+ T cells measured by nasal swabs

    2. Systemic T cell responses [Change from Baseline to 12 days post second vaccine dose]

      Cytokine responsiveness to SARS-CoV-2-specific CD4 and CD8+ T cells in blood

    3. Systemic and nasal antibody responses [Change from Baseline to 12 days post second vaccine dose]

      IgA and IgG responses to SARS-CoV-2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Manitoba
    • Public Health Agency of Canada (PHAC)
    • Cadham Provincial Lab

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Lyle Mckinnon, Assistant Professor, University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT04713163
    Other Study ID Numbers:
    • B2021:008
    First Posted:
    Jan 19, 2021
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    COVID-19
    Vaccines

    Study Results

    No Results Posted as of Jan 19, 2021