Covid19NCT04713163
COVID-19 Vaccine Induced Immunity
An observational study of Covid19, run by University of Manitoba.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- covid19 vaccine
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers eligible to receive Covid-19 vaccines
Who may be able to join
- all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
Who cannot join
- individuals under 18 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Evaluation of COVID-19 Vaccine Induced Immunity
This study aims to address the following three objectives:
- 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.
- 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.
- 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
- Being tested
- covid19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid19 vaccineDrug
Also called moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in Canada
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Health care or laboratory-based workers | Healthy individuals about to receive any approved COVID-19 vaccine Receives: Drug: covid19 vaccine | |
| Outpatients | Outpatients about to receive any approved COVID-19 vaccine Receives: Drug: covid19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal T cell responses
Phenotype of CD4 and CD8+ T cells measured by nasal swabs
Measured: 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
Measured: Change from Baseline to 12 days post second vaccine dose
Systemic and nasal antibody responses
IgA and IgG responses to SARS-CoV-2
Measured: Change from Baseline to 12 days post second vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Cadham Provincial Lab
- Responsible party
- Principal investigator, Lyle Mckinnon, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713163
- Sponsor's protocol ID
- B2021:008
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of COVID-19 Vaccine Induced Immunity
- ClinicalTrials.gov ID
- NCT04713163
- Acronym / sponsor ID
- B2021:008
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Cadham Provincial Lab
- Study start
- Jan 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to address the following three objectives:
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care or laboratory-based workers | – | Drug: covid19 vaccineHealthy individuals about to receive any approved COVID-19 vaccine |
| Outpatients | – | Drug: covid19 vaccineOutpatients about to receive any approved COVID-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers eligible to receive Covid-19 vaccines
Key inclusion criteria (1 listed)
- all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
Key exclusion criteria (1 listed)
- individuals under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| covid19 vaccineAlso: moderna or Pfizer mRNA vaccines, or any other vaccine for Covid19 that becomes approved in CanadaVaccine | Drug | Health care or laboratory-based workers, Outpatients |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyle R Mckinnon, PhD (2049757708, lyle.mckinnon@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal T cell responses (time frame: Change from Baseline to 12 days post second vaccine dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.