Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination

NCT ID: NCT04842305

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2024-03-15

Brief Summary

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The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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G1: Control group

SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls)

Blood- and saliva tests

Intervention Type DIAGNOSTIC_TEST

Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

G2: COVID-19 infected

Persons who have had COVID-19

Blood- and saliva tests

Intervention Type DIAGNOSTIC_TEST

Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

G3: COVID-19 vaccinated

Persons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S

Blood- and saliva tests

Intervention Type DIAGNOSTIC_TEST

Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

G4: COVID-19 infected and vaccinated

Individuals who have been infected with COVID-19 and subsequently been vaccinated

Blood- and saliva tests

Intervention Type DIAGNOSTIC_TEST

Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

Interventions

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Blood- and saliva tests

Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Both Hospital staff as well as non-health care workers will be invited to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lenanrt Friis-Hansen

OTHER

Sponsor Role lead

Responsible Party

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Lenanrt Friis-Hansen

Department of Clinical Biochemistry MD, DMSc, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Lennart Friis-Hansen, Dr.med.

Role: CONTACT

Other Identifiers

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P-2021-224

Identifier Type: -

Identifier Source: org_study_id

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