COVID-19 Vaccine Induced Immunity

Covid19 Clinical Trial

Official title:

Prospective Evaluation of COVID-19 Vaccine Induced Immunity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04713163
• Other study ID #: B2021:008
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: University of Manitoba
• Contact: Lyle R Mckinnon, PhD
• Phone: 2049757708
• Email: lyle.mckinnon[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• covid19 vaccine
Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Cadham Provincial Lab, Public Health Agency of Canada (PHAC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Systemic and nasal antibody responses	IgA and IgG responses to SARS-CoV-2	Change from Baseline to 12 days post second vaccine dose