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

NCT04996238 | Completed

• 1 other identifier: BC-09476
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

serum; nasal secretions; immune response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  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.

  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.

  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.

  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.

  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)

Study Arms (1)

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

OTHER

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18-100 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Vlaams Instituut voor Biotechnologie: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, East Flanders, 9860, Belgium

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Linos Vandekerckhove, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 9, 2021
• Study Start: February 11, 2021
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

BE (1)