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Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers (COVACC2)

Primary Purpose

Covid19

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

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

About this trial

This is an interventional basic science trial for Covid19 focused on measuring serum, nasal secretions, immune response

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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)

Outcomes

Primary Outcome Measures

Change in SARS-CoV-2 neutralization antibody levels.

In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum.

Secondary Outcome Measures

Change in tumor necrosis factor alpha (TNF-α) levels.

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

Change in interferon gamma (IFN-γ) levels.

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

Change in interleukin 2 (IL-2) levels.

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

Change in interleukin 1 (IL-1) levels.

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

Change in interleukin 18 (IL-18) levels.

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

Change in granulocyte-macrophage colony-stimulating factor (GM-CSF) levels.

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

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.

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.

Full Information

NCT ID

NCT04996238

First Posted

July 5, 2021

Last Updated

January 9, 2023

Sponsor

University Hospital, Ghent

Collaborators

University Ghent, Vlaams Instituut voor Biotechnologie

1. Study Identification

Unique Protocol Identification Number

NCT04996238

Brief Title

Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers

Acronym

COVACC2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

July 5, 2022 (Actual)

Study Completion Date

July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

Collaborators

University Ghent, Vlaams Instituut voor Biotechnologie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

serum, nasal secretions, immune response

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

218 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Change in SARS-CoV-2 neutralization antibody levels.

Description

In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum.

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)

Secondary Outcome Measure Information:

Title

Change in tumor necrosis factor alpha (TNF-α) levels.

Description

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

Time Frame