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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Blood- and saliva tests

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Lennart Friis-Hansen, Dr.med.; Phone Number: 61145916; Email: lennart.jan.friis-hansen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who belong to one of the following four groups will be included G1=SARS-COV-2 Naïve (=Not SARS-CoV-2 vaccinated and COVID-19 negative), G2=COVID-19 convalescents, G3=Vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine, G4=COVID-19 positive and vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G1: Control group; SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls)	Diagnostic test: Blood- and saliva tests; Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
G2: COVID-19 infected; Persons who have had COVID-19	Diagnostic test: Blood- and saliva tests; 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	Diagnostic test: Blood- and saliva tests; 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	Diagnostic test: Blood- and saliva tests; Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lenanrt Friis-Hansen

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: covid19; vaccination; saliva; sars-cov-2 antibodies; mucosal immunity; spike glycoprotein
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: P-2021-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No