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

NCT ID: NCT04996238

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-07-05

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.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

Vlaams Instituut voor Biotechnologie

UNKNOWN

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linos Vandekerckhove, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital Ghent

Ghent, East Flanders, Belgium

Countries

Belgium

Other Identifiers

BC-09476

Identifier Type: -

Identifier Source: org_study_id