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

Lenanrt Friis-Hansen

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: Blood- and saliva tests

Study type: Observational

Funder types: Other

Identifiers

NCT04842305

P-2021-224

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent
• Both Hospital staff as well as non-health care workers will be invited to participate

Exclusion criteria

• Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
• Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.

Trial design

500 participants in 4 patient groups

G1: Control group

Description:

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

Treatment:

Diagnostic Test: Blood- and saliva tests

G2: COVID-19 infected

Description:

Persons who have had COVID-19

Treatment:

Diagnostic Test: Blood- and saliva tests

G3: COVID-19 vaccinated

Description:

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

Treatment:

Diagnostic Test: Blood- and saliva tests

G4: COVID-19 infected and vaccinated

Description:

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

Treatment:

Diagnostic Test: Blood- and saliva tests