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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

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.

Condition or disease Intervention/treatment
Covid19 Drug: covid19 vaccine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prospective Evaluation of COVID-19 Vaccine Induced Immunity
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
Health care or laboratory-based workers
Healthy individuals about to receive any approved COVID-19 vaccine
Drug: covid19 vaccine
Vaccine
Other Name: 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 Name: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers eligible to receive Covid-19 vaccines
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713163


Contacts
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Contact: Lyle R Mckinnon, PhD 2049757708 lyle.mckinnon@umanitoba.ca
Contact: Blake Ball, PhD 2047892000 tblake.ball@canada.ca

Sponsors and Collaborators
University of Manitoba
Public Health Agency of Canada (PHAC)
Cadham Provincial Lab
  Study Documents (Full-Text)

Documents provided by Lyle Mckinnon, University of Manitoba:
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Responsible Party: Lyle Mckinnon, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04713163    
Other Study ID Numbers: B2021:008
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs