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Completed

NCT Number: NCT04996238

Local and General Immune Response After Coronavirus Disease (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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, East Flanders, 9860, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    Quantitative measurement of TNF-α in blood using an immunoassay.

  2. 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)

    Quantitative measurement of IFN-γ in blood using an immunoassay.

  3. 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)

    Quantitative measurement of IL-2 in blood using an immunoassay.

  4. 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)

    Quantitative measurement of IL-1 in blood using an immunoassay.

  5. 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)

    Quantitative measurement of IL-18 in blood using an immunoassay.

  6. 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)

    Quantitative measurement of GM-CSF in blood using an immunoassay.

  7. 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)

    Quantitative measurement of subsets of COVID-19 specific T cell responses with markers of immune activation using flow cytometry.

  8. 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)

    Quantitative measurement of SARS-CoV-2 Spike RBD binding B cells using flow cytometry.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Flemish institute of biotechnology (VIB)
  • University Ghent

Registry information

Official study title

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

Acronym: COVACC2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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