Official Title
COVACC2: Local and General Immune Response After COVID-19 Vaccination in Volunteers
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.

Completed
COVID19

Procedure: Blood and nasal fluid sampling before and after COVID-19 vaccination

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
Belgium
Locations

University Hospital Ghent
Ghent, East Flanders, Belgium

Linos Vandekerckhove, PhD, Principal Investigator
University Hospital, Ghent

University Hospital, Ghent
NCT Number
Keywords
serum
nasal secretions
immune response
MeSH Terms
COVID-19