COVID-19 Vaccine Induced Immunity

NCT04713163 | Unknown FDA Drug

• 1 other identifier: B2021:008
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to address the following three objectives:

1. 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. 2.Identification of cellular and soluble factors that influence vaccine responsiveness:
3. 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Health care or laboratory-based workers

Healthy individuals about to receive any approved COVID-19 vaccine

Drug: covid19 vaccine

Outpatients

Outpatients about to receive any approved COVID-19 vaccine

Drug: covid19 vaccine

Interventions

covid19 vaccine DRUG

Vaccine

Also known as: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada

Health care or laboratory-based workers; Outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers eligible to receive Covid-19 vaccines

You may qualify if:

• all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.

You may not qualify if:

• individuals under 18 years of age

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Lyle R Mckinnon, PhD

CONTACT

2049757708; lyle.mckinnon@umanitoba.ca

Blake Ball, PhD

CONTACT

2047892000; tblake.ball@canada.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share