Covid19COVACC2NCT04996238
Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers
A study testing Blood and nasal fluid sampling before and after COVID-19 vaccination in people with Covid19, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Blood and nasal fluid sampling before and after COVID-19 vaccination
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2021to 5 Jul 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18-100 years)
Who cannot join
- People with a compromised immune system Active treatment with chemotherapy HIV infection with cluster of differentiation 4 (CD4) count below 200/µl Combined immunodeficiency Treatment with methylprednisolone >16mg for more then 2 weeks Transplant patients Diagnosed Chronic Rhinosinusitis with Nasal Polyps
- Known pregnancy at the time of screening
- Inability to give informed consent or absence of legal representative who can give informed consent.
- Any contra indication for receiving the SARS-CoV2 vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVACC2: Local and General Immune Response After COVID-19 Vaccination in Volunteers
This study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines.
Read the detailed description
The immunological assays that will be performed on blood include immunophenotyping, serologic testing and cytokine analysis. Deep characterization of patients' immune profile offers a unique opportunity for comprehensive understanding of the mechanisms behind severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination. The investigators will study immunological functions on the level of both adaptive and innate immunity by performing extensive immunophenotyping, cytokine analysis and RNA sequencing analysis. Biomarker analysis will be performed on protein and on RNA single cell level. Infectivity of different cell types including macrophages will performed. These analyses will be performed at the Human Immunodeficiency Virus (HIV) Cure Research Center (HCRC) laboratory.
Nasal fluid: The investigators will compare the immune response and immunoglobulin production in nasal secretions before and after SARS-CoV2 vaccination. The investigators aim to compare the local versus the systemic (blood/serum) response to SARS-CoV2 vaccination. Further, patients that had a proven SARS-CoV2 infection will be compared with patients that never had COVID-19 symptoms nor antibodies.
Questionnaire: a questionnaire will be filled in by the individual to assess if the individual went through a previous SARS-CoV2 infection and experienced symptoms post vaccination. The questionnaires are available as supplementary documents.
- Conditions
- Covid19
- Being tested
- Blood and nasal fluid sampling before and after COVID-19 vaccination
- Keywords
- serum, nasal secretions, immune response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and nasal fluid sampling before and after COVID-19 vaccinationProcedure or surgery
Blood and nasal fluid sampling take place just before the first COVID-19 vaccination and at 14-30 days after the second dose with the same vaccine. Sampling will be repeated at 6 months after the second vaccination, at 14-30 days after the third vaccination and at 6 months after the third vaccination. At all moments, a questionnaire is filled in.
| Study group | Role | What they receive |
|---|---|---|
| Blood and nasal fluid sampling before and after COVID-19 vaccination | Other | Blood and nasal fluid will be collected just before the first vaccination (T1: pre-vaccination), between 14 and 30 days after the second vaccination (T2: post-vaccination), 6 months after the second vaccination (T3: 6 months post-vaccination), between 14 and 30 days after the third/booster vaccination (T4: post-booster-vaccination) and 6 months after the third/booster vaccination (T5: 6 months post-booster-vaccination) Receives: Procedure: Blood and nasal fluid sampling before and after COVID-19 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SARS-CoV-2 neutralization antibody levels.
In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum.
Measured: Nasal secretions and serum will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Secondary outcomes (8)
Change in tumor necrosis factor alpha (TNF-α) levels.
Quantitative measurement of TNF-α in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interferon gamma (IFN-γ) levels.
Quantitative measurement of IFN-γ in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 2 (IL-2) levels.
Quantitative measurement of IL-2 in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 1 (IL-1) levels.
Quantitative measurement of IL-1 in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 18 (IL-18) levels.
Quantitative measurement of IL-18 in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in granulocyte-macrophage colony-stimulating factor (GM-CSF) levels.
Quantitative measurement of GM-CSF in blood using an immunoassay.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change of subsets of T cells with markers Cluster of Differentiation 69 (CD69), CD40 ligand (CD40L), CD137.
Quantitative measurement of subsets of COVID-19 specific T cell responses with markers of immune activation using flow cytometry.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change of SARS-CoV-2 Spike Receptor Binding Domain (RBD) binding B cells.
Quantitative measurement of SARS-CoV-2 Spike RBD binding B cells using flow cytometry.
Measured: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start11 Feb 2021
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
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 Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
- Investigators
- Linos Vandekerckhove, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996238
- Sponsor's protocol ID
- BC-09476
- Acronym
- COVACC2
- Status last verified
- Jan 2023
- First submitted
- 5 Jul 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVACC2: Local and General Immune Response After COVID-19 Vaccination in Volunteers
- ClinicalTrials.gov ID
- NCT04996238
- Acronym / sponsor ID
- COVACC2 / BC-09476
- Conditions
- Covid19
- Keywords
- serum, nasal secretions, immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Flemish institute of biotechnology (VIB)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 9 Aug 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 gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines.
Detailed description
The immunological assays that will be performed on blood include immunophenotyping, serologic testing and cytokine analysis. Deep characterization of patients' immune profile offers a unique opportunity for comprehensive understanding of the mechanisms behind severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination. The investigators will study immunological functions on the level of both adaptive and innate immunity by performing extensive immunophenotyping, cytokine analysis and RNA sequencing analysis. Biomarker analysis will be performed on protein and on RNA single cell level. Infectivity of different cell types including macrophages will performed. These analyses will be performed at the Human Immunodeficiency Virus (HIV) Cure Research Center (HCRC) laboratory.
Nasal fluid: The investigators will compare the immune response and immunoglobulin production in nasal secretions before and after SARS-CoV2 vaccination. The investigators aim to compare the local versus the systemic (blood/serum) response to SARS-CoV2 vaccination. Further, patients that had a proven SARS-CoV2 infection will be compared with patients that never had COVID-19 symptoms nor antibodies.
Questionnaire: a questionnaire will be filled in by the individual to assess if the individual went through a previous SARS-CoV2 infection and experienced symptoms post vaccination. The questionnaires are available as supplementary documents.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and nasal fluid sampling before and after COVID-19 vaccination | Other | Procedure: Blood and nasal fluid sampling before and after COVID-19 vaccinationBlood and nasal fluid will be collected just before the first vaccination (T1: pre-vaccination), between 14 and 30 days after the second vaccination (T2: post-vaccination), 6 months after the second vaccination (T3: 6 months post-vaccination), between 14 and 30 days after the third/booster vaccination (T4: post-booster-vaccination) and 6 months after the third/booster vaccination (T5: 6 months post-booster-vaccination) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18-100 years)
Key exclusion criteria (4 listed)
- People with a compromised immune system Active treatment with chemotherapy HIV infection with cluster of differentiation 4 (CD4) count below 200/µl Combined immunodeficiency Treatment with methylprednisolone >16mg for more then 2 weeks Transplant patients Diagnosed Chronic Rhinosinusitis with Nasal Polyps
- Known pregnancy at the time of screening
- Inability to give informed consent or absence of legal representative who can give informed consent.
- Any contra indication for receiving the SARS-CoV2 vaccination
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 |
|---|---|---|
| Blood and nasal fluid sampling before and after COVID-19 vaccinationBlood and nasal fluid sampling take place just before the first COVID-19 vaccination and at 14-30 days after the second dose with the same vaccine. Sampling will be repeated at 6 months after the second vaccination, at 14-30 days after the third vaccination and at 6 months after the third vaccination. At all moments, a questionnaire is filled in. | Procedure or surgery | Blood and nasal fluid sampling before and after COVID-19 vaccination |
Primary outcome
Change in SARS-CoV-2 neutralization antibody levels.
Time frame: Nasal secretions and serum will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum.
8 secondary outcomes
Change in tumor necrosis factor alpha (TNF-α) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interferon gamma (IFN-γ) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 2 (IL-2) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 1 (IL-1) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in interleukin 18 (IL-18) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change in granulocyte-macrophage colony-stimulating factor (GM-CSF) levels.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change of subsets of T cells with markers Cluster of Differentiation 69 (CD69), CD40 ligand (CD40L), CD137.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Change of SARS-CoV-2 Spike Receptor Binding Domain (RBD) binding B cells.
Time frame: Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
Linos Vandekerckhove, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and nasal fluid sampling before and after COVID-19 vaccination in people with Covid19, run by University Hospital, Ghent at 1 site in Belgium.
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 4 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: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARS-CoV-2 neutralization antibody levels. (time frame: Nasal secretions and serum will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination)). 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 11 Jan 2023.