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COVID-19 Vaccine Induced Immunity

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ClinicalTrials.gov Identifier: NCT04713163
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Cadham Provincial Lab
Information provided by (Responsible Party):
Lyle Mckinnon, University of Manitoba

Tracking Information
First Submitted Date January 12, 2021
First Posted Date January 19, 2021
Last Update Posted Date January 19, 2021
Estimated Study Start Date January 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2021)
  • Nasal T cell responses [ Time Frame: 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 [ Time Frame: Change from Baseline to 12 days post second vaccine dose ]
    Cytokine responsiveness to SARS-CoV-2-specific CD4 and CD8+ T cells in blood
  • Systemic and nasal antibody responses [ Time Frame: Change from Baseline to 12 days post second vaccine dose ]
    IgA and IgG responses to SARS-CoV-2
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Vaccine Induced Immunity
Official Title Prospective Evaluation of COVID-19 Vaccine Induced Immunity
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.

  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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population healthy volunteers eligible to receive Covid-19 vaccines
Condition Covid19
Intervention Drug: covid19 vaccine
Vaccine
Other Name: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada
Study Groups/Cohorts
  • Health care or laboratory-based workers
    Healthy individuals about to receive any approved COVID-19 vaccine
    Intervention: Drug: covid19 vaccine
  • Outpatients
    Outpatients about to receive any approved COVID-19 vaccine
    Intervention: Drug: covid19 vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 14, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lyle R Mckinnon, PhD 2049757708 lyle.mckinnon@umanitoba.ca
Contact: Blake Ball, PhD 2047892000 tblake.ball@canada.ca
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04713163
Other Study ID Numbers B2021:008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lyle Mckinnon, University of Manitoba
Study Sponsor University of Manitoba
Collaborators
  • Public Health Agency of Canada (PHAC)
  • Cadham Provincial Lab
Investigators Not Provided
PRS Account University of Manitoba
Verification Date January 2021