Clinical trial NCT04996238: Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers
Official title: COVACC2: Local and General Immune Response After COVID-19 Vaccination in Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: serum
nasal secretions
immune response
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Vlaams Instituut voor Biotechnologie
First posted: 2021-08-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult (18-100 years)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in SARS-CoV-2 neutralization antibody levels.
timeFrame: 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:
measure: Change in tumor necrosis factor alpha (TNF-α) levels.
timeFrame: 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)
measure: Change in interferon gamma (IFN-γ) levels.
timeFrame: 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)
measure: Change in interleukin 2 (IL-2) levels.
timeFrame: 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)
measure: Change in interleukin 1 (IL-1) levels.
timeFrame: 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)
measure: Change in interleukin 18 (IL-18) levels.
timeFrame: 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)
measure: Change in granulocyte-macrophage colony-stimulating factor (GM-CSF) levels.
timeFrame: 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)
measure: Change of subsets of T cells with markers Cluster of Differentiation 69 (CD69), CD40 ligand (CD40L), CD137.
timeFrame: 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)
measure: Change of SARS-CoV-2 Spike Receptor Binding Domain (RBD) binding B cells.
timeFrame: 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)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Linos Vandekerckhove, PhD
role: PRINCIPAL_INVESTIGATOR
References: