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

Study Overview
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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.

Official Title
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Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Blood- and saliva tests


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G1: Control group<br>SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls) | Diagnostic Test: Blood- and saliva tests<br>* Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva<br>|
| G2: COVID-19 infected<br>Persons who have had COVID-19 | Diagnostic Test: Blood- and saliva tests<br>* Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva<br>|
| G3: COVID-19 vaccinated<br>Persons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S | Diagnostic Test: Blood- and saliva tests<br>* Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva<br>|
| G4: COVID-19 infected and vaccinated<br>Individuals who have been infected with COVID-19 and subsequently been vaccinated | Diagnostic Test: Blood- and saliva tests<br>* Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma | Detection of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma in participants who have been infected with COVID-19, vaccinated with Pfizer-BioNTech/Moderna mRNA-1273/AstraZeneca or infected and vaccinated | Between 21 and 200 days after infection/vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma | Comparison of SARS-CoV-2 spike glycoprotein RBD antibodies (in saliva and plasma) between participants vaccinated with Pfizer-BioNTech, Moderna mRNA-1273 and AstraZeneca | Between 21 and 200 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sars-cov-2 antibodies, saliva, mucosal immunity, vaccination, covid19, spike glycoprotein