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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Procedure: Blood and nasal fluid sampling before and after COVID-19 vaccination

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9860
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Blood and nasal fluid sampling before and after COVID-19 vaccination; 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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SARS-CoV-2 neutralization antibody levels.	In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum.	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 Measures

Outcome Measure	Measure Description	Time Frame
Change in tumor necrosis factor alpha (TNF-α) levels.	Quantitative measurement of TNF-α in blood using an immunoassay.	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.	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.	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.	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.	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.	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.	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.	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)

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent; Vlaams Instituut voor Biotechnologie
• Investigators: Principal Investigator: Linos Vandekerckhove, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: serum; immune response; nasal secretions
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BC-09476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No