Skip to content

COVID-19 Vaccine Induced Immunity

Prospective Evaluation of COVID-19 Vaccine Induced Immunity

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04713163
Enrollment
200
Registered
2021-01-19
Start date
2021-01-31
Completion date
2021-12-31
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DRUGcovid19 vaccine

Vaccine

Sponsors

Public Health Agency of Canada (PHAC)
CollaboratorOTHER_GOV
Cadham Provincial Lab
CollaboratorUNKNOWN
University of Manitoba
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Nasal T cell responsesChange from Baseline to 12 days post second vaccine dosePhenotype of CD4 and CD8+ T cells measured by nasal swabs
Systemic T cell responsesChange from Baseline to 12 days post second vaccine doseCytokine responsiveness to SARS-CoV-2-specific CD4 and CD8+ T cells in blood
Systemic and nasal antibody responsesChange from Baseline to 12 days post second vaccine doseIgA and IgG responses to SARS-CoV-2

Contacts

Primary ContactLyle R Mckinnon, PhD
lyle.mckinnon@umanitoba.ca2049757708
Backup ContactBlake Ball, PhD
tblake.ball@canada.ca2047892000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026