COVID-19 Vaccine Induced Immunity

Prospective Evaluation of COVID-19 Vaccine Induced Immunity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: covid19 vaccine

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lyle R Mckinnon, PhD; Phone Number: 2049757708; Email: lyle.mckinnon@umanitoba.ca
• Study Contact Backup: Name: Blake Ball, PhD; Phone Number: 2047892000; Email: tblake.ball@canada.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers eligible to receive Covid-19 vaccines

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Public Health Agency of Canada (PHAC); Cadham Provincial Lab

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: B2021:008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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